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Biocon - Intimation Of Record Date For Commercial Papers
30 Apr 2025, 8:14PM
Intimation of record date for Commercial Papers
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Biocon - Redemption Of Commercial Papers
29 Apr 2025, 7:59PM
Redemption of Commercial Papers
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Biocon - General Updates
29 Apr 2025, 7:55PM
Biocon Limited has informed the Exchange about Redemption of Commercial Papers
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Biocon - General Updates
26 Apr 2025, 11:25AM
Biocon Limited has informed the Exchange about Company Statement dated April 26, 2025
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Biocon - Company Statement Dated April 26, 2025
26 Apr 2025, 11:20AM
Company Statement Dated April 26, 2025
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Biocon - Alteration Of Capital and Fund Raising-XBRL
23 Apr 2025, 8:39PM
BIOCON LIMITED has informed the Exchange regarding Alteration of capital
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Biocon - Alteration Of Capital and Fund Raising-XBRL
23 Apr 2025, 8:36PM
BIOCON LIMITED has informed the Exchange regarding Issuance of securities
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Biocon - Outcome of Board Meeting
23 Apr 2025, 8:11PM
Biocon Limited has informed the Exchange regarding Outcome of Board Meeting held on April 23, 2025.
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Biocon - Board Meeting Outcome for Outcome Of Board Meeting
23 Apr 2025, 8:00PM
Outcome of Board Meeting
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Biocon - General Updates
22 Apr 2025, 8:16PM
Biocon Limited has informed the Exchange about issue of Commercial Papers
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Biocon - Issue Of Commercial Papers
22 Apr 2025, 8:14PM
Issue of Commercial Papers
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Biocon - Board Meeting Intimation
21 Apr 2025, 11:17AM
BIOCON LIMITED has informed the Exchange about Board Meeting to be held on 23-Apr-2025 to consider Fund raising.
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Biocon - Board Meeting Intimation for To Consider And Approve The Proposal For Raising Of Funds.
20 Apr 2025, 2:16PM
Biocon Ltdhas informed BSE that the meeting of the Board of Directors of the Company is scheduled on 23/04/2025 ,inter alia, to consider and approve T
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Biocon secures top credit rating from India Ratings for Rs 1,200 cr commercial paper program
16 Apr 2025, 11:12AM
Biocon Ltd has received a strong credit endorsement from India Ratings and Research (Ind-Ra), which has assigned a rating of ‘IND A1 ’ to
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Biocon - Credit Rating
15 Apr 2025, 7:54PM
Biocon Limited has informed the Exchange about Credit Rating
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Biocon - Announcement under Regulation 30 (LODR)-Credit Rating
15 Apr 2025, 7:51PM
Intimation on Credit Rating
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Biocon - Press Release
15 Apr 2025, 8:18AM
Biocon Limited has informed the Exchange regarding a press release dated April 15, 2025, titled ""Biocon Biologics Secures Market Entry Date for Yesaf
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Biocon has submitted to BSE the Shareholding Pattern for the Period Ended March 31, 2025
15 Apr 2025, 4:50PM
As of March 2025, 60.64% is owned by Promoters, 39.15% by Public and 0.21% by Non Promoters-Non Public.
<p align=justify>
Among Promoters holding, Ind
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Biocon - Announcement under Regulation 30 (LODR)-Press Release / Media Release
15 Apr 2025, 8:15AM
Press Release
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Biocon - Certificate under SEBI (Depositories and Participants) Regulations, 2018
14 Apr 2025, 4:34PM
Biocon Limited has informed the Exchange about Certificate under SEBI (Depositories and Participants) Regulations, 2018
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Biocon - Updates
10 Apr 2025, 10:04PM
Biocon Limited has informed the Exchange regarding 'Notification to Stock Exchanges'.
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Biocon - Notification To Stock Exchanges
10 Apr 2025, 9:45PM
Notification to Stock Exchanges
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Biocon - Updates
10 Apr 2025, 6:00PM
Biocon Limited has informed the Exchange regarding 'Certificate pursuant to SEBI Master Circular no. SEBI/HO/DDHS/PoD1/P/CIR/2024/54dated May 22, 2024
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Biocon - Certificate Pursuant To SEBI Master Circular No. SEBI/HO/DDHS/Pod1/P/CIR/2024/54\r\nDated May 22, 2024.
10 Apr 2025, 5:51PM
Certificate pursuant to SEBI Master Circular no. SEBI/HO/DDHS/PoD1/P/CIR/2024/54 dated May 22, 2024
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Biocon - Press Release
10 Apr 2025, 8:35AM
Biocon Limited has informed the Exchange regarding a press release dated April 10, 2025, titled ""Biocon Biologics Announces U.S. FDA Approval for Job
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Biocon - Disclosure under SEBI Takeover Regulations
8 Apr 2025, 4:24PM
Kiran Mazumdar Shaw has Submitted to the Exchange a copy of Disclosure under Regulation 31(4) of the Securities and Exchange Board of India (Substanti
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Biocon - Outcome of Board Meeting
4 Apr 2025, 8:56PM
Biocon Limited has informed the Exchange regarding Board meeting held on April 04, 2025.
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Biocon - Board Meeting Outcome for Outcome Of Board Meeting - Disclosure Under Reg 30
4 Apr 2025, 8:56PM
Issuance of Commercial Papers up to an amount not exceeding Rs. 600 Crores in one or more tranches on private placement basis
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Biocon - Analysts/Institutional Investor Meet/Con. Call Updates
2 Apr 2025, 5:20PM
Biocon Limited has informed the Exchange about Schedule of meet
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Biocon - Board Meeting Intimation
2 Apr 2025, 5:15PM
BIOCON LIMITED has informed the Exchange about Board Meeting to be held on 08-May-2025 to consider and approve the Yearly Audited Financial results of
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Biocon - Shareholders meeting
2 Apr 2025, 3:51PM
Biocon Limited has submitted the Exchange a copy Srutinizers report of Postal Ballot. Further, the company has informed the Exchange regarding voting
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Biocon - Announcement under Regulation 30 (LODR)-Analyst / Investor Meet - Intimation
2 Apr 2025, 5:19PM
Earnings Conference Call
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Biocon - Board Meeting Intimation for Board Meeting Intimation
2 Apr 2025, 5:12PM
Biocon Ltdhas informed BSE that the meeting of the Board of Directors of the Company is scheduled on 08/05/2025 ,inter alia, to consider and approve B
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Biocon - Shareholder Meeting / Postal Ballot-Scrutinizer\s Report
2 Apr 2025, 3:43PM
Postal Ballot Results
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Biocon - Shareholder Meeting / Postal Ballot-Outcome of Postal_Ballot
2 Apr 2025, 3:41PM
Postal Ballot Results
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Biocon - Change in Directors/ Key Managerial Personnel/ Auditor/ Compliance Officer/ Share Transfer Agent
1 Apr 2025, 10:49PM
BIOCON LIMITED has informed the Exchange about Change in Directors/ Key Managerial Personnel/ Auditor/ Compliance Officer/ Share Transfer Agent
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Biocon - Cessation
1 Apr 2025, 10:43PM
Biocon Limited has informed the Exchange regarding Cessation of Mr Peter Bains as Other of the company w.e.f. April 01, 2025.
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Biocon - Board Meeting Intimation
1 Apr 2025, 9:06PM
BIOCON LIMITED has informed the Exchange about Board Meeting to be held on 04-Apr-2025 to consider Fund raising.
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Biocon - Board Meeting Intimation for Intimation For The Board Meeting Pursuant To Regulation 29(1)(D) Of The Securities And
1 Apr 2025, 8:59PM
Biocon Ltdhas informed BSE that the meeting of the Board of Directors of the Company is scheduled on 04/04/2025 ,inter alia, to consider and approve I
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Biocon - Action(s) taken or orders passed
29 Mar 2025, 3:26PM
Biocon Limited has informed the Exchange regarding cautionary emails received from NSE and BSE dated March 28, 2025.
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Biocon - Announcement Under Regulation 30
29 Mar 2025, 3:15PM
Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015
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Biocon - Updates
28 Mar 2025, 6:06PM
Biocon Limited has informed the Exchange regarding 'Reminder Letter to shareholders for claiming Unclaimed dividend and Updation of KYCInformation'.
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Biocon - Reminder Letter To Shareholders For Claiming Unclaimed Dividend And Updation Of KYC Information
28 Mar 2025, 6:05PM
Reminder letters to shareholders
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Biocon - Trading Window-XBRL
28 Mar 2025, 3:38PM
Biocon Limited has informed the Exchange about Closure of Trading Window
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Biocon - Trading Window
28 Mar 2025, 3:34PM
Biocon Limited has informed the Exchange regarding the Trading Window closure pursuant to SEBI (Prohibition of Insider Trading) Regulations, 2015
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Biocon - Updates
24 Mar 2025, 8:52AM
Biocon Limited has informed the Exchange regarding 'Notification to Stock Exchange'.
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Biocon - Notification To Stock Exchange
24 Mar 2025, 8:58AM
Notification to stock exchange
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Biocon - Press Release
7 Mar 2025, 6:39PM
Biocon Limited has informed the Exchange regarding a press release dated March 07, 2025, titled ""Biocon Biologics Announces Positive Results from Pha
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Biocon - Announcement under Regulation 30 (LODR)-Press Release / Media Release
7 Mar 2025, 6:38PM
Press Release
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Biocon - Press Release
6 Mar 2025, 5:33PM
Biocon Limited has informed the Exchange regarding a press release dated March 06, 2025, titled ""Biocon Biologics and Civica, Inc. Collaborate to Exp
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Biocon - Analysts/Institutional Investor Meet/Con. Call Updates
6 Mar 2025, 12:43PM
Biocon Limited has informed the Exchange about Schedule of meet
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Biocon - Announcement under Regulation 30 (LODR)-Press Release / Media Release
6 Mar 2025, 5:32PM
Press Release
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Biocon - General Updates
4 Mar 2025, 6:26PM
Biocon Limited has informed the Exchange about General Updates
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Biocon - Notification To Stock Exchanges
4 Mar 2025, 6:25PM
Notification to Stock Exchanges
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Biocon - Press Release
4 Mar 2025, 11:26AM
Biocon Limited has informed the Exchange regarding a press release dated March 04, 2025, titled ""Biocon Academy Conducts its 9th Graduation Day "".
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Biocon - Announcement under Regulation 30 (LODR)-Press Release / Media Release
4 Mar 2025, 11:30AM
Press Release
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Biocon - Press Release
28 Feb 2025, 6:05PM
Biocon Limited has informed the Exchange regarding a press release dated February 28, 2025, titled ""Biocon Foundation Marks 20 Years of Transforming
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Biocon - Announcement under Regulation 30 (LODR)-Press Release / Media Release
28 Feb 2025, 6:04PM
Press Release
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Biocon - Copy of Newspaper Publication
28 Feb 2025, 2:25PM
Biocon Limited has informed the Exchange about Copy of Newspaper Publication
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Biocon launches Glucagon-like peptide-1 (GLP -1), Liraglutide in UK
28 Feb 2025, 9:54AM
An innovation-led global biopharmaceutical company, Biocon Limited today announced the launch of its GLP-1 peptide, Liraglutide, for diabetes and obes
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Biocon - Press Release
28 Feb 2025, 8:53AM
Biocon Limited has informed the Exchange regarding a press release dated February 28, 2025, titled ""Biocon Limited launches its Glucagon-like peptide
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Biocon - Announcement under Regulation 30 (LODR)-Press Release / Media Release
28 Feb 2025, 8:50AM
Press Release
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Biocon - Notice Of Shareholders Meetings-XBRL
27 Feb 2025, 6:49PM
Biocon Limited has informed the Exchange about Notice of Shareholders Meeting for Postal Ballot
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Biocon - Shareholders meeting
27 Feb 2025, 6:45PM
Biocon Limited has informed the Exchange regarding Notice of Postal Ballot
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Biocon - Shareholder Meeting / Postal Ballot-Notice of Postal Ballot
27 Feb 2025, 6:43PM
Postal Ballot Notice
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Biocon - General Updates
25 Feb 2025, 3:48PM
Biocon Limited has informed the Exchange about General Updates
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Biocon - Press Release
24 Feb 2025, 5:01PM
Biocon Limited has informed the Exchange regarding a press release dated February 24, 2025, titled ""Biocon Biologics Launches Yesintek (ustekinumab-
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Biocon - Announcement under Regulation 30 (LODR)-Press Release / Media Release
24 Feb 2025, 4:58PM
Press Release
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Biocon - Updates
18 Feb 2025, 8:37AM
Biocon Limited has informed the Exchange regarding 'Notification to Stock Exchange'.
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Biocon - Notification To Stock Exchange
18 Feb 2025, 8:41AM
Notification to Stock Exchange
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Biocon - Updates
17 Feb 2025, 4:57PM
Biocon Limited has informed the Exchange regarding 'Record Date Intimation for Commercial Papers'.
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Biocon - Record Date Intimation For Commercial Papers
17 Feb 2025, 4:49PM
Record Date Intimation for Commercial Papers
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Biocon - Press Release
11 Feb 2025, 3:11PM
Biocon Limited has informed the Exchange regarding a press release dated February 11, 2025, titled ""Biocon Foundation Dedicates Metro Pillars Public
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Biocon - Announcement under Regulation 30 (LODR)-Press Release / Media Release
11 Feb 2025, 3:07PM
Press Release
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Biocon - Announcement under Regulation 30 (LODR)-Analyst / Investor Meet - Intimation
7 Feb 2025, 5:33PM
Management of the Company is scheduled to meet with Investors on February 13, 2025 and February 17, 2025 in Mumbai
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Biocon - Analysts/Institutional Investor Meet/Con. Call Updates
7 Feb 2025, 5:15PM
Biocon Limited has informed the Exchange about Schedule of meet
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Biocon - Announcement under Regulation 30 (LODR)-Analyst / Investor Meet - Intimation
7 Feb 2025, 5:09PM
Management of the Company is scheduled to meet with Investors on February 13, 2025 and February 15, 2025 in Mumbai
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Biocon - Announcement under Regulation 30 (LODR)-Earnings Call Transcript
7 Feb 2025, 3:53PM
Transcript of Q3 FY 25 Earnings Call
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Biocon - Analysts/Institutional Investor Meet/Con. Call Updates
7 Feb 2025, 3:47PM
Biocon Limited has informed the Exchange about Transcript
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Biocon - Announcement under Regulation 30 (LODR)-Press Release / Media Release
6 Feb 2025, 6:42PM
Press Release
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Biocon - Press Release
6 Feb 2025, 6:39PM
Biocon Limited has informed the Exchange regarding a press release dated February 06, 2025, titled ""Equillium Inc. and Biocon Limited Announce Positi
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Biocon - Updates
3 Feb 2025, 1:45PM
Biocon Limited has informed the Exchange regarding 'Corporate Presentation'.
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Biocon - Copy of Newspaper Publication
1 Feb 2025, 2:58PM
Biocon Limited has informed the Exchange about Copy of Newspaper Publication
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Biocon - General Updates
1 Feb 2025, 1:28PM
Biocon Limited has informed the Exchange about Disclosure under Regulation 30 of SEBI(LODR) Regulations, 2015
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Biocon - Disclosure Under Regulation 30 Of SEBI (LODR) Regulations, 2015
1 Feb 2025, 1:34PM
Intimation under Regulation 30 of SEBI Listing Regulations
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Biocon
28 Apr 2025 , 10:35AM
Biocon’s arm Biocon Biologics receives positive EMA CHMP opinions recommending approval of denosumab biosimilars Vevzuo® and Denosumab BBL which are used in the treatment of osteoporosis. Positive
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Biocon gets USFDA nod for norepinephrine bitartrate injection
24 Mar 2025 , 9:58AM
Norepinephrine bitartrate injection treats acute hypotension
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Biocon
10 Mar 2025 , 9:03AM
Arm Biocon Biologics reported positive Phase 3 study results for Yesintek, a biosimilar to Ustekinumab, used for chronic plaque psoriasis. Positive
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Biocon
7 Mar 2025 , 9:46AM
The company formed a strategic collaboration agreement with Civica Inc to expand access and affordability of Insulin Aspart in the United States. Insulin aspart is a fast-acting insulin injection used to treat type 1 and type 2 diabetes. Positive
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Biocon
5 Mar 2025 , 9:13AM
The company's subsidiary, Biocon Pharma has received final approvals for its two ANDAs - Lenalidomide capsules and Dasatinib tablets - from the US Food and Drug Administration (US FDA). Lenalidomide is used to treat multiple myeloma, mantle cell lymphoma, and anemia in myelodysplastic syndromes in adults. Dasatinib tablets are used to treat Philadelphia chromosome-positive chronic myeloid leukemia. Biocon Pharma also received tentative approval for its ANDA for Rivaroxaban tablets, which are used in the treatment of deep vein thrombosis and pulmonary embolism.
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Biocon launches Glucagon-like peptide-1 (GLP -1), liraglutide in the UK
28 Feb 2025 , 9:54AM
GLP-1 peptide, liraglutide is used for treatment of diabetes & obesity
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Biocon
7 Feb 2025 , 12:18PM
Equillium Inc & Co have announced positive results from their Phase two study evaluating Itolizumab for the treatment of moderate to severe Ulcerative Colitis.
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Biocon
13 Jan 2025 , 11:59AM
USFDA classifies Biocon Biologics’ site in Johor, Malaysia as Voluntary Action Indicated (VAI) following a cGMP inspection conducted in September 2024. Positive
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Biocon
13 Jan 2025 , 11:49AM
USFDA classifies Biocon Biologics’ site in Johor, Malaysia as Voluntary Action Indicated (VAI) following a cGMP inspection conducted in September 2024. Positive
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Biocon
3 Jan 2025 , 10:10AM
The company’s arm Biocon Pharma received approval for the Tacrolimus capsule from National Medical Products Administration, China. Tacrolimus is an immunosuppressant used in the treatment of organ transplant patients, which reduces the body’s ability to reject a transplanted organ. Positive
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Bicon
24 Dec 2024 , 10:51AM
Biocon, Zentiva receive decentralized procedure approval for Liraglutide
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Biocon
10 Dec 2024 , 10:46AM
Biocon to sell upto 2% stake in ‘Syngene International’ via block deals. Total deal size is around Rs. 660 crore. Positive.
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Biocon
9 Dec 2024 , 11:34AM
The company has received an establishment inspection report (EIR) with a voluntary action Indicated (VAI) status from the USFDA for its API facility (site 2) in Bengaluru. Positive read through
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Biocon
2 Dec 2024 , 10:48AM
Biocon: US FDA approves YESINTEK, a monoclonal antibody that is used to treat Crohn’s disease. Positive
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Biocon
26 Sep 2024 , 11:15AM
Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd announced new dermatology data presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam. The results from two separate pivotal Phase 3 clinical studies supported interchangeability between adalimumab and adalimumab-fkjp as well as underscoring biosimilarity of bUstekinumab.
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Biocon signs settlement & Licence Agmt with Janssen Biotech
29 Aug 2024 , 10:45AM
Biocon Signs Settlement & Licence Agmt w/Janssen Bio, To Mkt Bmab 1200 In Europe, UK, Canada & Japan
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Biocon
29 Aug 2024 , 10:22AM
Biocon Biologics Ltd , a fully integrated global biosimilars company and a subsidiary of Biocon Ltd announced today that the Company has signed a settlement and license agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara®, in Europe, the United Kingdom (UK), Canada, and Japan. Under the terms of this settlement agreement, Biocon Biologics has resolved patent disputes with Janssen to secure market entry dates in Europe, the UK, Canada, and Japan. Regulatory filingsin these markets are currently under review. (Positive)
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Biocon
13 Aug 2024 , 11:46AM
Stock Update: Biocon – Biosimilars continue to gain market share in regulated markets
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Biocon
6 Aug 2024 , 10:44AM
This is to inform you that the Company has received an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) from the U.S. Food and Drug Administration (USFDA), for our API facility (Site 5), located at Visakhapatnam, Andhra Pradesh. This is based on a GMP inspection conducted by the agency between the 17th and 21st of June, 2024. (Positive)
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Biocon
24 Jun 2024 , 1:51PM
The U.S. Food and Drug Administration (USFDA) concluded a GMP inspection of our API facility (Site 5), located at Visakhapatnam, Andhra Pradesh, on June 21, 2024. Four observations were cited at the end of the Inspection, which we will be addressing within the stipulated time. Biocon stands committed to Quality, Safety & Efficacy of the products manufactured.” (Neutral)
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Biocon
4 Jun 2024 , 10:18AM
Biocon has received approval from the U.S. Food and Drug Administration (US FDA), for its vertically integrated, complex injectable drug product, Micafungin (50mg and 100mg vials), used as an antifungal medication to treat fungal or yeast infections," according to a stock exchange filing. Micafungin is an antifungal medication used to treat a range of fungal and yeast infections. The approval further strengthens Biocon’s portfolio of vertically integrated, complex drug products. Positive.
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Biocon signs licensing deal with Handok INC
24 May 2024 , 11:05AM
Biocon signs exclusive licensing and supply deal for the commercialization of Liraglutide in South Korea with Handok Inc.
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Biocon
14 May 2024 , 10:07AM
Biocon Limited signs semi-exclusive distribution and supply deal for the commercialization of generic Saxenda® (Liraglutide) in Mexico with Medix. Under the terms of this agreement, Biocon will undertake the responsibility of obtaining regulatory approval, manufacturing and supply of the drug product, and Medix will be responsible for its commercialization in the Mexican market. Medix has been working for more than 70 years in developing solutions to address the overweight and obesity burden in a country where 70% of the population are dealing with the disease, to improve their quality of life. Positive
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Biocon
22 Apr 2024 , 11:34AM
Biocon: Company gets approval from South Africa regulatory authorities for Tacromilus capsule. (Positive)
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Biocon
18 Apr 2024 , 9:40AM
Biocon today announced the signing of an exclusive licensing and supply agreement with Biomm S.A., a specialty pharmaceutical company in Brazil, for the commercialization of its vertically integrated drug product, Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes. Under the terms of this agreement, Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market. Brazil is the fifth country in the world with the highest incidence of diabetes, having 16.8 million adults in the age group of 20 to 79 years with the disease, and an estimated 21.5 million cases by 2030, according to the Diabetes Atlas of the International Diabetes Federation (IDF). Positive
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Biocon receives UK Healthcare Department’s approval for Diabetes drug
28 Mar 2024 , 11:26AM
Biocon is the first generics Company to obtain approval for diabetes drug, Liraglutide, in the UK
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Biocon
28 Mar 2024 , 9:59AM
Biocon becomes the first generics company to get a diabetes drug approval in the UK. Biocon Ltd. has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) U.K., for its complex formulation Liraglutide, which was filed through its European partner, Zentiva. Liraglutide is a 6 mg / ml solution for injection in pre-filled pen. Positive
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Biocon Biologics signs 10-yr collaboration with Eris Life for branded formulation biz
14 Mar 2024 , 3:32PM
Biocon Biologics enters a long-term commercial collaboration with Eris Lifesciences to expand patient access in India
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Biocon Biologics secures canada market entry date for YESAFILI
4 Mar 2024 , 10:45AM
Biocon Biologics gets Canada market entry date for ophthalmic drug Yesafili
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Biocon
1 Mar 2024 , 12:36PM
The U.S. Food and Drug Administration (FDA) conducted an inspection at Biocon Biologics Limited’s Biocon Campus (Site 1) facility between February 20-28, 2024. This inspection pertains exclusively to the rh-Insulin (rhI) Drug Substance (DS) supply to a customer for veterinary use. The trigger for this inspection was a Pre-Approval Supplement (PAS) filed by our customer late last year. At the conclusion of this inspection, the agency has issued Form 483s with 4 observations. The Company will submit a comprehensive Corrective and Preventive Action (CAPA) Plan to the U.S. FDA within the stipulated time and is committed to addressing these observations expeditiously. (Negative)
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Biocon
26 Feb 2024 , 12:00PM
Biocon Generic, wholly owned step down subsidiary of the Company has issued Corporate Guarantee on behalf of Biocon Generics Inc, wholly owned step down subsidiary of the Company. Corporate Guarantee of USD 20 Mn is given in favour of Mizuho Bank Ltd to secure term loan facility of USD 20 Mn extended to Biocon Generics Inc by the Bank. The Corporate Guarantee is valid for 5 years. The Corporate Guarantee will be treated as a contingent liability for the Company. In the event of failure on the part of the borrower in repaying the same to the Bank, the Company has guaranteed the due repayment of the same. (Negative).
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Stock Update: Biocon
15 Feb 2024 , 11:24AM
Stock Update: Biocon Ltd - Balance sheet deleveraging on the cards
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Stock Update: Biocon
18 Jan 2024 , 12:00PM
Stock Update: Biocon : Balance sheet deleveraging on the cards; Upgrade Buy
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Biocon
26 Dec 2023 , 9:44AM
Biocon Biologics Partners with Sandoz for the Distribution of “Adalimumab BS Subcutaneous Injection [FKB]" in Japan. Based on this Agreement, Viatris has completed marketing and promotion of the product as of December 15, 2023, but will continue to provide transition support until Sandoz will gradually assume responsibilities for the product starting February 15, 2024. (Positive)
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Biocon
19 Dec 2023 , 11:21AM
Biocon Biologics Concludes Integration of Acquired Biosimilars Business in ~120 countries across Advanced and Emerging Markets, a year ahead of schedule. Over 10 Emerging Markets along with Japan, Australia and New Zealand have transitioned in this final phase of the integration of the biosimilars business acquired from Viatris. With the completion of this significant milestone, Biocon Biologics is now a unique, fully integrated ‘lab to market’ biosimilars company committed to serving millions of patients across the globe. Positive
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Biocon
15 Dec 2023 , 12:13PM
Bicara Therapeutics an associate company of Biocon Limited, has completed its US$165 Million Series C financing. The proceeds of the funding shall be used to support the continued advancement of Bicara’s lead product candidate, BCA101, a first-in-class bifunctional EGFR/TGF-β inhibitor that is currently in clinical development for multiple cancer types. Consequent to this infusion of Series C funding and post allotment of shares by Bicara, the Company’s shareholding in Bicara on fully diluted basis will fall below 20% and thereby, Bicara will cease to be an associate company of Biocon Limited. (Positive)
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Biocon
14 Dec 2023 , 10:45AM
Bicara Therapeutics an associate company of Biocon Limited, has completed its US$165 Million Series C financing. The proceeds of the funding shall be used to support the continued advancement of Bicara’s lead product candidate, BCA101, a first-in-class bifunctional EGFR/TGF-β inhibitor that is currently in clinical development for multiple cancer types. Consequent to this infusion of Series C funding and post allotment of shares by Bicara, the Company’s shareholding in Bicara on fully diluted basis will fall below 20% and thereby, Bicara will cease to be an associate company of Biocon Limited. (Positive)
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Biocon
1 Dec 2023 , 10:48AM
Biocon Biologics Successfully Completes Integration of Viatris’ Biosimilar Business in 31 Countries in Europe. Following the acquisition of substantially all the global biosimilar business of Viatris in November 2022, and the related integration of over 70 emerging market countries in July 2023 and North America in September 2023. In Europe, Biocon Biologics portfolio includes 7 biosimilars: Insulin Aspart and Insulin Glargine, Bevacizumab, Pegfilgrastim, Trastuzumab, Adalimumab, and Etanercept. At a global level, Biocon Biologics has a robust pipeline of 20 assets for diabetology, oncology, immunology, ophthalmology, and bone health. (Positive)
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Stock update – Biocon Q2FY24 results review
20 Nov 2023 , 12:35PM
Stock update – Biocon Q2FY24 results review: Challenges in launching products – Maintain Hold
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Stock update – Biocon Q2FY24 results review
20 Nov 2023 , 12:27PM
Stock update – Biocon Q2FY24 results review: Challenges in launching products – Maintain Hold
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Biocon
19 Oct 2023 , 4:15PM
Kedar Upadhye Appointed as New CFO of Biocon Biologics Current CFO MB Chinappa to take on a Strategic Finance role at Biocon Group. MB Chinappa has served as CFO of Biocon Biologics since his appointment in January 2020 and has played an integral role in developing business strategy and enabling profitable growth (Neutral).
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Biocon
18 Oct 2023 , 10:50AM
Biocon’s step-down subsidiary of Biocon Biologics Limited has received a communication from the U.S. Food and Drug Administration (FDA) pursuant to its July 2023 cGMP inspection at its insulins manufacturing facility at Johor, Malaysia. The FDA has determined the inspection classification as “OAI” (Official Action Indicated). The OAI status may cause delay and/or withholding of pending product approvals or supplements from the facility.
View – Receiving OAI status is negative for the company.
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Biocon
9 Oct 2023 , 11:44AM
Biocon Limited signs commercialization agreement with Juno Pharmaceuticals, a specialty pharmaceutical company in Canada for the commercialization of its vertically integrated, complex formulation, Liraglutide, a drug-device combination for the treatment and management of Type 2 diabetes and obesity. Biocon will be responsible for obtaining regulatory approval for Liraglutide, and thereafter, for the manufacture and supply of the product in the Canadian market.
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Biocon
20 Sep 2023 , 10:15AM
The company's board has approved the appointment of Mr. Peter Bains as Biocon Group Chief Executive Officer, w.e.f. September 18, 2023. Positive read through.
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Biocon
4 Sep 2023 , 10:28AM
The company’s, wholly-owned subsidiary, Biocon Generics Inc., has acquired Eywa Pharma Inc.’s oral solid dosage manufacturing facility, located in Cranbury, New Jersey, U.S., effective 1st September, 2023. The facility is acquired for a total consideration of US $7.7 million. As part of the acquisition, the existing workforce of the facility will transition to Biocon Generics Inc. The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year. The acquisition of this US FDA approved facility, will complement Biocon’s existing manufacturing capabilities and strengthen its foothold in the United States. The acquisition will also enable us to add oral solid dosage capacities for new products earlier than originally planned and ensure continuity of supply through the diversification of our manufacturing infrastructure – Positive read through for the stock.
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Biocon
24 Jul 2023 , 12:59PM
Biocon Ltd.: The company’s subsidiary Biocon Biologics announced positive CHMP opinion for Yesafili biosimilar Aflibercept. Positive.
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Biocon
24 Jul 2023 , 12:38PM
The USFDA conducted two cGMP inspections at Biocon Sdn. Bhd’s Insulin Manufacturing facility in Malaysia encompassing Biologics Drug Substance, Drug Products Unit, and Quality Control Laboratories as well as the Delivery Devices Unit. At the conclusion of these inspections, the agency issued Form 483 with 6 observations for Drug Substance, Drug Products Units, and Quality Control Laboratories as well as 2 observations for the Delivery Devices Unit. Negative.
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Biocon
6 Jul 2023 , 9:44AM
Biocon Biologics said it has completed the integration of the acquired biosimilars business from Viatris Inc in over 70 countries in emerging markets, effective July 1, 2023, which is expected to increase the scale and scope of its business.
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Biocon Biologics launches biosimilar adalimumab in US.
4 Jul 2023 , 12:40PM
Biocon Biologics' Hulio biosimilar to Humira, now available in US
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Biocon
4 Jul 2023 , 10:42AM
Biocon’s subsidiary, Biocon Biologics, announced launch of HULIO (adalimumab fkjp) injection, a biosimilar of Humira (adalimumab) in the US after marketing it in Europe for 5 years and 2 years in Canada. It is a part of Viatris’ portfolio of products. Highly positive for Biocon.
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Biocon
9 Jun 2023 , 10:04AM
Biocon has informed that its Active Pharmaceutical Ingredient (API) manufacturing facility located in Bangalore has received a certificate of GMP compliance from the Competent Authority of Germany, following an EU GMP inspection that was conducted in February 2023. Positive for the stock.
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Biocon
5 Jun 2023 , 10:26AM
The US FDA concluded a surveillance and pre-approval inspection of Biocon Pharma Limited Oral Solid Dosage formulations manufacturing facility at Bengaluru on 2nd June 2023, with no observations. Positive for the company.
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Biocon
2 Jun 2023 , 11:50AM
Biocon Ltd’s competitor, Coherus BioSciences is planning the launch of Biosimilar of Humira in the US at an 85.0% discount. Biocon had planned for a July 23’s launch of the drug. Viatris has the marketing authorization for the same. This is expected to be revenue growth weakening for the company as it was considered an important driver besides approvals and launches of Aspart and Bevacizumab of the growth for Viatris’ USD 1.1 billion revenue projection for FY24. Negative read through for the stock. We have downgraded it to HOLD from BUY recently with a PT of Rs. 266
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Biocon
2 May 2023 , 9:44AM
Biocon Biologics’ monoclonal antibodies drug substance manufacturing facility in Bengaluru has received a Certificate of GMP Compliance for an additional product biosimilar Bevacizumab from Health Products Regulatory Authority, Ireland. Earlier also, the facility had received EU GMP compliance certification for manufacturing biosimilar Trastuzumab last year. Positive read through for Biocon.
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Biocon
27 Apr 2023 , 12:58PM
Syngene international in which coverage company Biocon has 54.6% stake released its Q4FY23 results, yesterday, post market hours. The company which is into CRO/CDMO services delivered its own guidance beating growth for the quarter and year. The revenue increased 31.0% y-o-y to Rs. 994 Cr and PAT increased 21.0% y-o-y to Rs. 179 Cr. EBITDA margin declined marginally to 33.1% in Q4FY23 from 34.3% in Q4FYY22. The management stated that the company posted strong results in Q4FY23 led by growth across all segments, which, in turn, led to positive performance for FY23, which is ahead of its upgraded guidance. Positive for both Biocon and Syngene International.
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Biocon Biologics
25 Apr 2023 , 10:59AM
Serum & Biocon Biologics Agree to Restructure
Equity Investment
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Biocon
28 Mar 2023 , 2:21PM
Biocon Ltd. has won the “Bioprocessing Excellence in South Asia” award at the APAC Bioprocessing Excellence Awards (ABEA) 2023, held in Singapore earlier this month. The management believes it is a recognition of its longstanding expertise in process sciences, state of the art manufacturing capabilities, operational excellence, and high standards of quality compliance.
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Biocon
20 Mar 2023 , 11:19AM
AHAN - I LTD sold 1.89 crore shares in company. Negative read through for the stock
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Biocon Ltd.
23 Feb 2023 , 1:04PM
Biocon Ltd.: Biocon Ltd. has successfully redeemed its commercial papers worth Rs. 2,250 Cr.
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Biocon Ltd.
23 Feb 2023 , 12:57PM
Stock Update: Biocon Ltd. – Strong Q3 performance; Maintain Buy
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Biocon
8 Feb 2023 , 10:06AM
India ratings (Fitch Ratings) has assigned AA+ with stable outlook to Biocon to its proposed NCDs and reaffirmed its long-term issuer rating to AA+ with stable outlook. The ratings reflect Biocon’s strong positioning in the global biosimilar market with proven expertise in commercialising products in the developed markets of the US and EU. Moreover, India Ratings believes the company’s capability to compete meaningfully in the evolving biosimilar landscape will improve through its enhanced cost leadership post acquisition of Viatris’ biosimilar business, effective November 2022 through its subsidiary, BBL. Biocon’s interest in the acquired portfolio will increase to full economics from approximately one-third (earlier shared with Viatris), providing comfort to the cash flow generation without adding any new products. Ind-Ra believes Biocon will be able to comfortably meet its debt commitments over the medium term, given the structuring of the transaction. Furthermore, the company’s generics and the research services businesses continued to witness healthy cash generation in FY22. Positive read through for the stock.
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Biocon
23 Dec 2022 , 9:05AM
Company has announced that it was issued a Good Manufacturing Practice (GMP) certificate of compliance by the European Directorate for the quality of medicines and Healthcare (EDQM) for its API manufacturing facility in Bangalore. Our view: It is a positive development for the company.
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Biocon
15 Dec 2022 , 1:26PM
Biocon has announced the initiation of the clinical study of Itolizumab in patients with Ulcerative Colitis (UC) in India in collaboration with Equillium Inc. This is a phase II randomized study to evaluate the safety and efficacy of Itolizumab for the induction of remission in biologics naïve patients with moderate to severely active UC. The study has the approval from DCGI. Our view: Itolizumab is a high value, multi-indication biologic molecule. The clinical study will help the company to be able to offer these expensive treatments at affordable cost. We believe it is positive for the stock.
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Biocon Biologics completes acquisition of Viatris' global biosimilars biz
30 Nov 2022 , 10:44AM
Completes the multi-billion-dollar, value accretive transaction in partequity and part-cash
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Biocon Biologics completes acquisition of Viatris' global biosimilars biz
30 Nov 2022 , 10:43AM
Completes the multi-billion-dollar, value accretive transaction in partequity and part-cash
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Biocon
25 Nov 2022 , 11:28AM
Biocon Biologics has allotted equity shares worth Rs 2,205.63 crore (USD 270mn) to it as part of an equity infusion to fund the latter's acquisition of Viatris Inc's biosimilars business. In February this year, Biocon Biologics Ltd (BBL) inked a pact to acquire Viatris Inc's biosimilars business for consideration of up to USD 3.335 billion (about Rs 24,990 crore).
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Biocon
24 Nov 2022 , 9:14AM
Biocon Limited enters into a commercialization agreement with Zentiva in Europe – Positive read though for the stock. View: The company announces signing of a semi-exclusive partnership agreement with Zentiva, a leading pharmaceutical company in Europe, for the commercialization of its vertically integrated, complex formulation, Liraglutide, a drug-device combination for the treatment and management of Type 2 diabetes and obesity. Under the terms of this agreement Biocon will be responsible for the manufacturing and supply of Liraglutide to Zentiva, for its commercialization across 30 countries in Europe. Biocon will also retain the right to commercialize this product under its own brand in the region.
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Biocon
25 Oct 2022 , 10:20AM
Biocon Biologics’ integrated insulins manufacturing facility in Malaysia is approved by the European Medicines Agency following a site inspection in July 2022. The Company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland. This certificate enables the Company to continue addressing the needs of people with diabetes in the EU who require Insulin Glargine and Insulin Aspart. Also, the USFDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for Insulin Aspart filed by the company’s partner Viatris (Mylan). The CRL did not identify any outstanding scientific issues with the product. The company has submitted a CAPA (Corrective and Preventive Action) plan to the USFDA for review and is confident to resolve the observations. Positive read thru.
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Biocon
17 Oct 2022 , 2:42PM
Biocon Biologics Ltd., a subsidiary of Biocon Ltd. has entered into a strategic out-licensing agreement with Japanese pharmaceuticals company Yoshindo Inc. for commercializing two of its pipeline biosimilar assets, bUstekinumab and bDenosumab, in the Japanese market. Under the terms of this deal, Yoshindo gets exclusive commercialization rights in Japan for bUstekinumab and bDenosumab developed and manufactured by Biocon Biologics, for an addressable market opportunity of ~USD 700 million. Biocon Biologics will receive an upfront license fee as well as additional payments on the achievement of certain development milestones over the next few years. Positive read-thru for the stock.
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Biocon
7 Oct 2022 , 11:53AM
The European Directorate for the Quality of Medicines & HealthCare (EDQM) conducted a GMP inspection of an API manufacturing site of Biocon Limited in Bangalore from the 12th to 14th of September 2022 and issued a list of deficiencies on 5th October 2022. There were no critical deficiencies and one deficiency cited under the category ‘Major’. The company will be responding to the agency with appropriate corrective and preventive actions within the stipulated time.
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Biocon, Eris Lifesciences
10 Aug 2022 , 10:19AM
As per media news Eris Life sciences has entered in to an in-licensing deal with Biocon to market insulin glargine in India. Eris expects to launch insulin glargine in Q3FY23 and the product is already approved in the US and Europe. The launch of long acting insulin glargine will help Eris to fill the gap in its insulin portfolio and in the process would also add be positive for Biocon
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Biocon
6 Jul 2022 , 10:24AM
Biocon: following a GMP inspection in April 2022, the company gets a EU GMP certificate from the Health Products Regulatory Authority - Ireland, for its new monoclonal antibodies (mAbs) drug substance manufacturing facility (B3) at Biocon Park, Bengaluru. The plant is an integrated multi product facility. Receipt of the EU GMP certificate is positive
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Biocon
30 Jun 2022 , 2:36PM
Biocon: entered into an agreement for the purpose of acquisition of solar power by acquiring equity stake up to 26% in AMPYR Renewable Energy Resources Eleven Private Limited for a consideration of Rs 7.5 crore. AMPYR is a special purpose vehicle formed for generation and supply of solar power and it would develop a 30 mw power plant in Karnataka. The acquisition was done to enhance the renewable based power consumption. Sentim
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Biocon acquires equity stake up to 26% in AREREPL for Rs 7.5 cr
30 Jun 2022 , 9:42AM
Biocon has entered into an agreement for the purpose of acquisition of solar power
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Biocon
29 Jun 2022 , 10:36AM
The CBI has approached Delhi High Court challenging a lower court order denying it the custody of those arrested in the CDSCO bribery scandal, which also involved a senior executive of Biocon Biologics. Further the Delhi high court has issued notices to the concerned parties involved and would hear the case on 2nd July 2022. So despite of a favourable order issued by the lower court, the Delhi Higher court has summoned the parties involved pointing at a likely investigations. Further updates on the same are awaited. Stock to remain in Focus.
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Biocon
22 Jun 2022 , 11:44AM
Arm Biocon Biologics has issued its statement against media reports stating alleged bribery charges for favourably processing of Insulin Aspart files. The management strongly denies the allegations of bribery against it. Further it has clarified that basis clinical data it was seeking Waiver of Phase 3 Clinical Trials for Insulin Aspart in India. Biocon Biologics has conducted Phase 1 and Phase 3 trials with Aspart in Germany and USA, respectively, and based on the insulin Aspart has been granted approval by EMA and Health Canada. Collectively this removes the overhang on the stock. Positive read thru
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Biocon
22 Jun 2022 , 11:41AM
Arm Biocon Biologics has issued its statement against media reports stating alleged bribery charges for favourably processing of Insulin Aspart files. The management strongly denies the allegations of bribery against it. Further it has clarified that basis clinical data it was seeking Waiver of Phase 3 Clinical Trials for Insulin Aspart in India. Biocon Biologics has conducted Phase 1 and Phase 3 trials with Aspart in Germany and USA, respectively, and based on the insulin Aspart has been granted approval by EMA and Health Canada. Collectively this removes the overhang on the stock. Positive read thru
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Biocon
21 Jun 2022 , 11:56AM
As per media news, Biocon Biologics is accused of bribing Joint Drug Controller with a bribe of Rs 9 Lakhs for favourably processing the files for Insulin Aspart injection to the Subject matter Expert Committee (SEC) and has booked Mr L Praveen Kumar, Associate VP Biocon Biologics under the case. We await further details in the regard; Stock to be in focus
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Biocon
15 Jun 2022 , 9:59AM
Biocon: The competition commission of India (CCI) has approved the proposed transaction involving the sale of global biosimilars portfolio of Viatris Inc to Biocon Biologics Ltd and an equity infusion in Biocon Biologics by Biocon and Serum. The proposed transaction involves the sale of the global biosimilars portfolio of Viatris Inc to Biocon Biologics and its subsidiary for cash and stock consideration. The approval of both the transactions is positive as it would open up an array of opportunities for Biocon in its key markets.
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Biocon
10 Jun 2022 , 10:24AM
The US government has approved a plan which aims at making medicines and drugs affordable to all in the US. Basis this legislation, the price of Insulins is capped at $35 per month and is applicable to the population covered under the Government programs. While this legislation is likely to impact companies such as Eli Lilly, Sanofi and Novo Nordisk account for 90% of the overall market in the US Diabetic Drug markets, while Players such as Biocon have generic biosimilars – Insulin Glargine (Semglee) in the US markets which has recently also received an interchangeability status. We await further clarity if biosimilars would be a part of the price cap legislations, hence Biocon would be in focus today
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Biocon
9 Jun 2022 , 9:43AM
Biocon Biologics aims for a $1.8 bn revenues (translating to ~ Rs 13990 cr) for FY24 as compared to Rs 3464 crore in FY22, which is almost a three fold jump over FY22. The incremental revenues are expected form acquisition of Viatris’ biosimilar business ($1.1 bn of incremental revenues) and $300 million will come from SII (Serum Institute of India) alliance and $400 million from sales of biosimilars in domestic and emerging markets. The management in an interview has said that it is confident of closing FY24 with $1.8 bn of revenues, which provides visibility on the strong growth ahead. We have a Buy recommendation on Stock.
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Biocon
20 May 2022 , 9:49AM
Arm Biocon Biologics and partner Viatris has launched biosimilar – Abevmy in Canada in the Oncology space. After Ogivri and Fullphila, Abevmy is another oncology product by the company to be introduced in the Canada markets and would strengthen the Oncology segment presence in Canada markets. Positive
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Biocon
4 May 2022 , 9:45AM
Biologics arm - Biocon Biologics’ new monoclonal antibody drug substance manufacturing plant in Bengaluru had a GMP inspection from the Health Products Regulatory Authority (HPRA), Ireland between March 28 to April 1, 2022. The inspection has ended with no ‘critical’ observations and only one of the deficiencies is categorized as ‘major’ which is being addressed expeditiously in consultation with the regulatory agency. As the inspection has ended with no critical observations and it could help company cater to the additional requirements from the EU markets, hence positive read thru
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Biocon Q4FY22 Results: Strong quarter
29 Apr 2022 , 9:19AM
Biocon Q4FY22 Results: Strong quarter; results in line with estimates
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Biocon
27 Apr 2022 , 9:45AM
The subsidiary company of Biocon Biologics has bagged a three-year contract from the Malaysian government (Malaysian Ministry of Health) for the supply of recombinant human insulin brand Insugen. The contract is values at $90 mn (~Rs 688 crore). As per the deal terms the subsidiary company of Biocon biologics would manufacture and supply the doses to its partner company and this will in turn to the Malaysia government. The receipt of the contract offers substantial growth opportunities for Biocon Biologics, hence is positive
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Biocon bags 3-year contract worth $90 million
26 Apr 2022 , 8:53AM
Biocon Biologics' Insugen awarded a Three-Year contract by Ministry of Health, Malaysia
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Stock Update – Biocon
2 Mar 2022 , 12:42PM
Stock Update – Biocon: Acquisition to stress earnings in near term; long term levers stay intact
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Biocon Biologics to acquire Viatris' biosimilars assets for up to $3.335 bln
28 Feb 2022 , 10:23AM
Board of Directors of Biocon Biologics subsidiary of Biocon approves the proposed acquisition of biosimilars assets of Viatris Inc
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Biocon
28 Feb 2022 , 9:40AM
Subsidiary company Biocon Biologics Limited (BBL) has entered into a definitive agreement with its partner Viatris Inc to acquire Viatris’ biosimilars business, which would result in to creation of a fully integrated global biosimilars enterprise. The consideration for the said acquisition is $3.335 bn (~ Rs 25000 cr) which includes cash of up to $2.3 bn (~ Rs 17250 cr) and the balance would be through the issue of compulsorily Convertible preference shares in BBL to Mylan (Viatris’ group company). The cash consideration would be funded through $800 mn of cash raised in BBL and balance through debt or additional equity or a combination there of
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Biocon
8 Feb 2022 , 9:35AM
Biocon: Subsidiary company – Biocon Pharma gets USFDA approval for its ANDA - Posaconazole Delayed-Release tablets in the strength of 100 mg. the tablet is indicated for prevention of certain fungal infections in patients with severely weakened immune systems. The approval is positive as it would strengthen the company’s portfolio of vertically integrated complex drugs
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Stock Update: Biocon – Q3FY22 results review
24 Jan 2022 , 12:32PM
Stock Update: Biocon – Q3FY22 results review: Strong quarter; Growth levers intact
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Biocon Q3Fy22 Results: Q3FY22 Results
21 Jan 2022 , 10:50AM
Biocon Q3FY22 Results: Q3FY22 Results - Strong quarter; operating margins miss estimates
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Biocon
10 Jan 2022 , 10:57AM
The USFDA has issued a CRL (Complete Response Letter) for Insulin Aspart filed by partner Viatris, thus not approving the application filed by Viatris. The CRL has not identified of any outstanding scientific issues in the product and the management seems confident of replying to the CRL in the stipulated time frame. Negative read thru.
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Biocon
4 Jan 2022 , 12:28PM
Biocon: The board has approved a scheme of merger between Biocon Biologics and Covidshield Technologies Private Limited (CTPL), is a wholly-owned subsidiary of Serum Institute Life Sciences Private Limited (SILS). CTPL is engaged in the business of commercialisation of vaccines. As per the terms of the agreement, Biocon Biologics would get access to a 100 million doses per annum for 15 years, primarily from SILS’s upcoming vaccine facility in Pune with commercialization rights of the SILS vaccine portfolio (including COVID-19 vaccines) for global markets, while Biocon Biologics will generate a committed revenue stream and related margins, commencing H2 FY23. Also it would offer 15% stake to SILS and a board seat to Mr Adar Poonawala in Biocon Biologics. There is no cash consideration involved. As vaccines are a natural adjacency to BBL’s existing platform, merger with CTPL shall allow Biocon Biologics entry in the vaccine space, hence is a potential positive.
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Biocon Biologics partner Viatris wins US court decisions
31 Dec 2021 , 12:50PM
Biocon Biologics partner Viatris wins US Court Decisions on Sanofi Appeals for Lantus Device Patents
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Biocon
31 Dec 2021 , 9:48AM
The US court of Appeals for the Federal Circuit (USCAFC) has upheld the US Patent and Trademark Appeal Board’s decisions for unpatentability of five device patents for Sanofi’s Lantus SoloSTAR, as well as a district court decision on one of these patents. The PTAB and the US Patent and Trade Marks office had in April and May 2020 found the challenged claims un-patentable. As Biocon’s Semglee is the only interchangeable Biosimilar product to Lantus available in US, with substantial addressable market size as Lantus (100 units / ML) reported US sales of $1.4 bn while Solostar reported sales of $5.1 bn in the US for 12 months ending September 30, 2021. Therefore a favourable court judjement for Biocon and its partner – Viatris and a substantial addressable market size is positive development
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Biocon
24 Dec 2021 , 1:13PM
Partner company – Equillium Inc has expanded its EQUALISE, which is a clinical study for Systemic Lupus Erythematosus and Lupus Nephritis for Itolizumab (ALZUMAb) to clinical centres in India. Itolizumab is a first in class monoclonal antibody, that selectively targets pathways, which plays a central role in modulating the activity and trafficking of T cells that drive several immune-inflammatory diseases. Lupus, is an autoimmune chronic inflammatory disease and in India its prevalence is 3.2cases per 100,000. Itolizumab can address the unmet need for Lupus in India and hence can be a long term positive for Biocon, if the trials are successfully completed and the drug gets the regulatory approvals.
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Biocon
9 Dec 2021 , 11:35AM
As per media news, Biocon Is in talks with Mylan for the merger of its Biosimilars business – Biocon Biologics with Mylan’s biosimilar business. Biocon looks to hold a controlling stake in the merged entity and so Biocon could look at options to buy out stake from Mylan to that extent. As both the companies have partnered already for a broad portfolio of products across several markets, the merger if successful could offer significant synergies in the form of scale benefits. Biocon in the past has done several rounds of fund raise in Biocon Biologics and the last deal values Biologics business at $5bn and going ahead the merged entity may look at an IPO seeking valuation of $10 bn. If successful the merger could provide value unlocking opportunity and hence positive
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Biocon
7 Dec 2021 , 10:24AM
Biocon: Enters in to a partnership with Tabuk Pharmaceutical Manufacturing company, which is a leading company in Middle East and North Africa (MENA) region, to commercialize selected specialty products. As per the terms of the agreement Tabuk would hold marketing authorization and will be responsible to register, import, and promote products in Saudi Arabia and other Middle East countries, while Biocon would develop and manufacture the products. The partnership is positive as it enables Biocons expansion in the MENA region to countries like - Saudi Arabia, UAE, Kuwait, Qatar, Oman and Iraq, in addition to Jordan and Lebanon.
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Biocon gets USFDA nod for generic product
3 Dec 2021 , 2:24PM
Biocon gets approval for ANDA for Mycophenolic acid from USFDA
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Biocon
3 Dec 2021 , 9:45AM
Biocon Pharma, a subsidiary of the company, has received approval from the USFDA for its ANDA for for Mycophenolic Acid. This product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and is available in 180mg and 360mg strengths. This approval further adds to Biocon’s portfolio of vertically integrated complex drug products and hence positive.
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Bicon
22 Nov 2021 , 11:52AM
Partner Viatris and Biocon Biologics have announced that Insulin Glargine injection will be offered through Walgreens Prescription Savings Club, saving members up to 80% off the cash price of comparable long-acting insulins purchased at Walgreens. This is positive as it would improve the access / penetration for Insulin glargine.
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Biocon
17 Nov 2021 , 9:57AM
Biocon Biologics and partner Viatris has announced the launch of interchangeable biosimilars SEMGLEE (insulin glargine) injection – in branded as well as unbranded format in the US markets. The biosimilar is used to control high blood sugar in adult and pediatric patients with type 1 diabetes and type 2 diabetes. Both biosimilar products are interchangeable for the reference brand, LANTUS, allowing for substitution at the pharmacy counter. The interchangeable biosimilars launch in the US markets offers substantial growth opportunities for Biocon Biologics and hence is a positive.
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Biocon
8 Nov 2021 , 9:54AM
Subsidiary - Biocon Biologics Limited and its partner Viatris Inc have announced that Prime Therapeutics, a leading pharmacy benefit manager in the US, serving nearly 33 million members, will list Semglee (branded product for Insulin Glargine) and an unbranded version of Insulin Glargine as preferred insulin over the reference brand - Lantus on its national formularies. The development is positive for Biocon as the receipt of the Interchangeability status allows for substitution for the reference product at the pharmacy counter.
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Biocon
18 Oct 2021 , 10:06AM
The USFDA has approved the first biogeneric medicine for the US markets, thus pointing at a likely increase in the price pressures and further expected approvals in the biogeneric space. Thus the competitive pressures are likely to increase for Biocon, hence could be negative.
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Biocon
4 Oct 2021 , 11:07AM
Has launched Everolimus tablets in the US in the strength of 2.5mg, 5mg, 7.5mg and 10mg, with the 10 mg tablet being a ‘day-1’ generic launch. Everolimus tablet is a prescription medication that is used to treat certain types of cancers and tumours. The launch is in line with the strategy of focus on vertically integrated complex Finished dosages. US sales of Everolimus tablets were approximately $675 mn for the 12 months ending July 2021. Given the sizeable addressable market size, the launch is positive as would further strengthen the company’s presence in the oncology space.
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Biocon launches Everolimus Tablets in the US
4 Oct 2021 , 10:40AM
Biocon expands its Generic Formulations portfolio with the launch of Everolimus tablets in the US
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Biocon Biologics insulin manufacturing facility in Malaysia completes USFDA inspection
27 Sep 2021 , 12:09PM
At the conclusion of the inspection, the agency has issued a Form 483 with a total of 6 observations across Drug Substance
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Biocon
27 Sep 2021 , 9:48AM
The USFDA conducted an onsite per approval inspection (PAI) of company’s Malaysian subsidiary’s manufacturing facility for Insulin Aspart between Sep 13 and Sep 24, 2021. The inspection concluded with a form 483 with 6 observations across Drug Substance, Drug Product and Devices Facilities. Management is confident of addressing these observations through procedural enhancements and Corrective and Preventive Action Plan and looks to submit its responses within the stipulated time frame. Further the outcome of the inspection is unlikely to impact the commercialization plans for insulin Aspart in the US. However, the receipt of the Form 483 with 6 observations is sentimentally negative.
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Biocon
8 Sep 2021 , 9:40AM
The company along with its subsidiaries Biocon Pharma Limited and Biocon Pharma Inc. have entered in to a confidential settlement agreement with Celgen corporation pertaining to settlement of patents for Revlimid. Further details regarding the terms of settlement are awaited, however the settlement agreement could remove the overhang on the stock and hence could be potential positive.
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Biocon
29 Jul 2021 , 10:32AM
The USFDA has approved the first interchangeable biosimilar insulin product - Semglee, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee is the first interchangeable biosimilar product in the US and is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus. This is positive for Biocon as it could lead to a substantial growth for Semglee.
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Biocon Biologics to make new antibody to fight, prevent COVID
27 Jul 2021 , 10:56AM
Biocon Biologics partners with Adagio Therapeutics to advance antibody for the Prevention and Treatment of COVID-19
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Biocon
27 Jul 2021 , 9:09AM
Adagio Therapeutics has granted an exclusive license to Biocon Biologics to manufacture and commercialize an antibody treatment based on ADG20 for India and select emerging markets. ADG20, a novel monoclonal antibody targeting the spike protein of SARS-CoV-2 (Covid-19) and related coronaviruses. The drug is in global clinical development by Adagio as a single agent for both the treatment and prevention of COVID-19 including its variants. ADG20 offers easy administration as a single, intramuscular injection for the treatment of Covid 19. Adagio plans to seek Emergency Use Authorization in the US in first quarter of 2022 and as per the terms of agreement Biocon Biologics will get access to the clinical and nonclinical data from Adagio’s EUA submission to seek approvals in the emerging markets. This granting of license is positive as it would further strengthen the Covid portfolio for Biocon and would also drive the topline growth
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Biocon Limited Q1FY2022 Result update
26 Jul 2021 , 10:48AM
Biocon Limited Q1FY2022 Result update: Weak quarter; Growth levers intact
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Biocon Q1FY22: Weak quarter
23 Jul 2021 , 9:38AM
Biocon Q1FY22: Weak quarter; results missed estimates
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Biocon Limited Q4FY2021 Result update
30 Apr 2021 , 11:51AM
Biocon Limited Q4FY2021 Result update: Long-term growth levers intact
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Biocon Q4FY21
29 Apr 2021 , 9:45AM
Biocon Q4FY21: Adjusting for one offs PAT below estimates
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Biocon
26 Apr 2021 , 9:35AM
Subsidiary company Biocon Biologics has announced that Abevmy® 100 & 400 mg, a biosimilar of Bevacizumab co-developed with Viatris Inc has received marketing authorization approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway. Biosimilar of Bevacizumab is approved for treating various types of Cancer. The approval is positive as it would strengthen the portfolio of biosimilars for treating cancers in the EU and would also add to the topline of Biocon Biologics
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Biocon receives GMP compliance certificate from MHRA, UK
12 Apr 2021 , 10:53AM
Biocon arm Biocon Pharma gets GMP compliance certificate from UK regulator
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Biocon
30 Mar 2021 , 10:25AM
Biocon: wholly owned subsidiary company – Biocon Pharma Limited has entered in to a partnership with Brazil based, Libbs Farmaceutica to launch generic drugs in Brazil markets. As per the terms of the licensing agreement, Biocon Pharma will be responsible for drug development and manufacturing, while Libbs will leverage its deep expertise and reach in Brazil to import, distribute and market the drugs in Brazil, subject to receipt of regulatory approvals. The arrangement is positive for Biocon as it would enable it to expand its geographical reach, which in turn would aid topline growth.
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Biocon
30 Mar 2021 , 8:59AM
Biocon subsidiary Biocon Pharma has partnered with Libbs Farmaceutica to launch generic formulations in Brazil.
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Biocon
22 Mar 2021 , 10:23AM
The company has incorporated a wholly owned subsidiary company - Biofusion Therapeutics Limited on 18th March 2021. The Authorised capital and paid up capital of the new incorporated company is Rs 15 lakhs and Rs 5 lakhs respectively. Biofusion Therapeutics Limited business would in the field of Research and Development and allied services.
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Biocon
9 Mar 2021 , 10:59AM
Subsidiary Biocon Biologics has received subscription amount of Rs 555 crore from the wholly-owned subsidiary of ADQ. The board of Biocon Biologics has approved the allotment of 1.97 crore shares at an issue price of Rs 280.3 per share. The deal was announced in the month of January 2021 and the same been completed now.
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Biocon
1 Mar 2021 , 10:45AM
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization for the company’s biosimilar Bevacizumab, co-developed with Viatris. The drug would be marketed under the brand Abevmy (injection bevacizumab 100mg and 400mg). The decision from the European Commission for the drug approval is expected in May 2021 and approval would grant marketing authorization in the 27 European Union. Biocon expects the UK marketing authorization to come in shortly after European Commission decision. The opinion adopted by the CHMP is positive as it would help growth the Biosimilars business.
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Biocon Biologics to partner with International Diabetes Federation
16 Feb 2021 , 11:56AM
Biocon Biologics joins hands with IDF in its mission to promote Diabetes Care, prevention and effective management worldwide
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Biocon
12 Feb 2021 , 9:33AM
Subsidiary company Biocon Biologics has received an approval for Kixelle, biosimilar Insulin Aspart co-developed with Viatris Inc. from the European Commission following positive recommendation from Committee for Medicinal Products for Human Use of the Europe Medicine Agencies. Kixelle, a fast-acting insulin analog indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. The approval is valid in all EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway. The approval is positive as it would drive the sales of the Biocon Biologics upwards.
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Biocon
5 Feb 2021 , 10:09AM
Biocon: Subsidiary company Biocon Biologics has signed a pact with Clinton Health Access Initiative (CHAI) to expand access to lifesaving cancer biosimilars as a part of the Cancer Access Partnership (CAP). Basis the agreement Biocon Biologics would provide affordable biosimilar cancer therapies in 25 countries in Africa and 5 countries in Asia, which are currently covered under CAP. Initially the company would offer bpegfilgrastim and bTrastuzumab and later on would expand the arrangement to include other biosimilars as well. The arrangement is positive as it would facilitate geographic expansion of the company’s biosimilars portfolio which would potentially add to the topline growth.
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Biocon Ltd Q3FY21 Result update
25 Jan 2021 , 12:52PM
Biocon Limited Q3FY21 Result update: Near-term hiccups; long-term growth levers intact
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Biocon reports weak Q3 earnings
22 Jan 2021 , 10:05AM
Biocon Q3FY21 Weak quarter; PAT missed estimates
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Biocon
8 Jan 2021 , 10:04AM
Subsidiary company Biocon Biologics has approved equity investment by Abu Dhabi based - ADQ. As per the terms of the proposed agreement, ADQ will invest Rs 555 Crore for a 1.80% minority stake in the biosimilar business, valuing Biocon Biologics at a post money valuation of ~$ 4.17 bn. The fund infusion is a part of the company’s overall plan of value unlocking.
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Biocon
5 Jan 2021 , 10:49AM
As per media reports, Intas Pharma has received exclusive license to commercialize trastuzumab injection in the US and Canada. This can lead to increased competition for Biocon in these markets and hence negative.
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Biocon launches Tacrolimus capsules in US
29 Dec 2020 , 10:20AM
Drug has an estimated market size of $300 million
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Biocon arm’s USFDA inspection delayed
28 Dec 2020 , 3:54PM
Biocon arm’s USFDA inspection delayed
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Biocon
16 Dec 2020 , 9:39AM
Biocon Biologics, a subsidiary of the company has signed a Memorandum of Understanding (MoU) with the Christian Social Services Commission (CSSC), a faith-based organization active in Africa. Tanzania will be the first country in Africa that will benefit from this collaboration. global insulins player, Biocon Biologics is helping unlock universal access to quality insulins in low- and middle-income countries by making recombinant human insulin available for less than 10 U.S. cents per day as a part of its ‘Mission 10 cents’ program. In addition the company is also working towards strengthen overall healthcare capacity inthese countries. The MoU would be positive as it would open up new growth avenues for the company.
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Biocon
15 Dec 2020 , 10:16AM
Biocon Biologics and Mylan have received a positive recommendation from the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) for the marketing approval of their biosimilar insulin aspart candidate (Kixelle). Insulin Aspart is a rapid-acting insulin and is used for treatment of type 1 and type 2 diabetes. Basis the positive recommendation from the CHMP, the final authorization from the European Commission is expected in early 2021. This development is positive for Biocon as it points at likely approval for Insulin Aspart in the European region.
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Biocon
13 Nov 2020 , 10:32AM
The company has received an approval from USFDA for Tacrolimus. The drug is used to treat the symptoms of eczema - atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes. The approval is positive as it would add to the US sales.
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Biocon
9 Nov 2020 , 10:29AM
Subsidiary company Biocon biologics had received a capital infusion of Rs 1,125 crore ($150 mn) from Goldman Sachs for an implied stake of 3.8% and translating in to a valuation of $3.94 bn for Biocon Biologics. As per the proposed terms of the agreement, Biocon biologics would issues optionally convertible debentures to Goldman Sachs. The fund infusion is a part of the company’s overall plan of value unlocking
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Biocon: Q2FY2021 Result Update
26 Oct 2020 , 11:22AM
Biocon: Q2FY2021 Result Update – Soft Quarter; Promising Outlook
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Biocon Q2FY21 muted quarter
23 Oct 2020 , 10:55AM
Biocon Q2FY21 Muted quarter; PAT missed estimates
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Biocon
6 Oct 2020 , 10:55AM
As per media news, the company’s repurposed psoriasis drug - Itolizumab has seen sevenfold jump in sales after it got an emergency use authorisation for Covid-19 treatment. Itolizumab is yet to be included as part of the clinical management protocol of the health ministry for treatment of Covid-19, which implies that the government has not yet recommended it as an effective treatment. However the company has commenced phase-4 clinical trials of the drug. If the data is supportive from the trials, the demand for the drug may see a sharp surge.
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Biocon Biologics, Mylan announce launch of Semglee
1 Sep 2020 , 12:21PM
Biocon Biologics, Mylan announce launch of Semglee in the US to expand access for patients living with Diabetes
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Biocon
1 Sep 2020 , 9:21AM
Biocon: Launches Semglee (insulin glargine injection) in the U.S. to treat diabetes: positive as it would substantially boost the performance of the Biologics business.
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Biocon
31 Jul 2020 , 11:47AM
Tata Capital growth fund to invest $30 mn in Biocon Biologics, translating to around Rs 225 cr for a stake of 0.85%. The deal values Biocon Biologics. at an equity valuation of Rs 26,250 Crore, (~USD 3.5 billion), and an enterprise valuation of Rs 30,400 Crore, (~USD 4.0 billion). The previous fund raising done was at a valuation of around 22000 crores. Post the completion of the transaction Biocon would hold 95.25% stake in Biocon Biologics. This is positive for Biocon as it provides value unlocking opportunities.
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Biocon
27 Jul 2020 , 11:14AM
Biocon – Q1FY21 Viewpoint update - Biologics – a key growth driver
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Biocon
24 Jul 2020 , 11:04AM
Biocon Q1FY21 strong performance; results better than estimates
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Biocon
24 Jul 2020 , 10:03AM
Biocon reported a strong performance for Q1FY21 driven by a better than estimated performance of the Biologics segment. The revenues grew 14.6% yoy on the back of double digit growth in Biologics and small molecules segment. The OPM’s at 24.7% were ahead of estimates. The operating profits at Rs 413 cr also was ahead of estimates. Tracking the operating profit, the PAT at Rs 152 cr was ahead of the estimates.
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Biocon
21 Jul 2020 , 12:10PM
Subsidiary Biocon Biologics and Voluntis have announced a global collaboration agreement to develop and distribute innovative digital therapeutics solutions, supporting people with diabetes on biologics therapy. The licensing agreement will make Biocon Biologics one of the first insulins companies to offer USFDA approved and CE marked highly validated digital therapeutic product, Insulia, to Type 2 diabetes patients, across several markets in the world. Insulia provides automated insulin dose recommendations enabling people with diabetes to self-manage their condition and healthcare teams to remotely monitor progress. This is positive as the digital therapeutic solution would complement Biocon’s offering in the anti diabetic space and would add to the topline growth.
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Biocon Biologics, Voluntis join hands for global collaboration
21 Jul 2020 , 10:24AM
Biocon Biologics & Voluntis in agreement for global collaboration on Digital Therapeutics for Insulins
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Biocon Biologics, Voluntis join hands for global collaboration
21 Jul 2020 , 10:24AM
Biocon Biologics & Voluntis in agreement for global collaboration on Digital Therapeutics for Insulins
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Biocon
14 Jul 2020 , 9:19AM
As per media reports, partner Equillium is planning to conduct a global randomised controlled clinical trial of Itolizumab in COVID-19 patients in the US, for which it will file a investigational new drug application with the USFDA. Potentially positive for Biocon if the trials are successful and drug is approved
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Biocon receives DCGI nod for use of Itolizumab drug
13 Jul 2020 , 10:21AM
Biocon's breakthrough drug Itolizumab receives DCGI nod for its use in moderate to severe COVID-19 patients
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Biocon
8 Jul 2020 , 9:48AM
Biocon Limited: Viewpoint Update - Biologics to be key growth driver
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Biocon
3 Jul 2020 , 11:28AM
The company expects to invest a sum of USD 200 mn (Rs 1500 crore) as capex for FY2021. The capex will be split equally between small molecules and the biosimilars businesses and will be funded through a combination of contribution from internal accruals, debt raise as well as additional private equity investment in Biocon Biologics. In FY2020 the capex spends stood at Rs 974 cr and was towards new manufacturing facility in Visakhapatnam for immunosuppressant products under the small molecules segment
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Biocon
22 Jun 2020 , 10:52AM
Subsidiary company Biocon Pharma has entered in to an agreement with DKSH Business Unit Healthcare. As per the agreement DKSH will sell and distribute seven of Biocon Pharma’s generic formulations in Singapore and Thailand. DKSH will gain an exclusive license to register and commercialize these seven generic formulations belonging to various therapeutic areas like diabetology, cardiology, oncology and immunology. This development is in line with Biocon’s strategy for expansion of its generic formulations segment through licensing route and could drive the growth in the segment. Positive
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Biocon
12 Jun 2020 , 11:30AM
The USFDA has approved Mylan and Biocon’s co-developed New Drug Application (NDA) for Semglee (insulin glargine injection), in vial and pre-filled pen presentations. The medicine is used to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes. Semglee has an identical amino acid sequence to that of Sanofi’s Lantus and is approved for the same indications. Sanofi’s reported annual sales for 12 months ending April 2020 at $1.68 bn for Lantus 100 Units/mL Vial and approximately $4.33 billion for Lantus SoloSTAR Pen. Considering the huge size of opportunity available, we believe this approval is Positive as it would boost the performance of the Biologics segment. The management has stated that it is confident of getting a double digit market share and is on track to launch the drug in Q2FY21
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Biocon, Mylan gets USFDA nod for Semglee
12 Jun 2020 , 9:40AM
Biocon and Mylan announce USFDA approval of Semglee
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Biocon
1 Jun 2020 , 9:15AM
The US Patent and Trademark Appeal Board (PTAB) has ruled in favour of Mylan, Biocon’s partner in inter partes review (IPR) proceedings, finding all challenged claims of Sanofi SA’s Lantus (insulin products to treat diabetes –in vials forms) and SoloSTAR (disposable insulin injection pen) device patents, to be un patentable. The announcement would further strengthen Biocon’s resolve to provide a high quality affordable Insulin Glargine to diabetic patients in the U.S. Biocon’s NDA application for Smeglee (Insulin Glargine) is under active review by the USFDA and the company anticipates a launch in mid CY2020. As per IQVIA, Lantus and SoloStar sales in the US stood at $1.7 bn and $4.32 bn for 12 month ending March 2020. This points at a substantially large size of opportunity for Biocon’s product and hence is positive.
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Biocon Biologics receives DCGI approval for emergency use of CytoSorb
27 May 2020 , 9:51AM
Biocon Biologics receives DCGI approval for emergency use of CytoSorb to treat critical COVID-19 patients
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Biocon
27 May 2020 , 9:43AM
Subsidiary company Biocon Biologics has received an approval from the DCGI (Drug Controller General Of India) for an extracorporeal blood purification device CytoSorb to reduce pro-inflammatory cytokines levels in confirmed COVID-19 patients admitted to the intensive care unit with respiratory failure. Biocon Biologics has been granted emergency use license for CytoSorb to treat Covid-19 patients and this license would be effective until control of Covid-19 outbreak in India. Positive as this could add to the topline growth.
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Biocon
19 May 2020 , 9:43AM
Subsidiary Biocon Biologics has received the Certificate of GMP compliance from EMA (EU) for multiple Biologics Drug Substance (DS) and Drug Product (DP) manufacturing facilities at Bengaluru. These facilities are used for the manufacture of DS and DP for Biosimilars: Bevacizumab, Trastuzumab, Pegfilgrastim and secondary packaging of Insulin Glargine for EU markets, and were inspected in March 2020. This approval expands Biocon Biologics’ capacities multi-fold to address the growing needs of patients in the EU markets for Trastuzumab and Pegfilgrastim. Positive as this would boost the performance of the Biologics business.
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Biocon unit gets EU GMP certification in Bengaluru
19 May 2020 , 9:42AM
Biocon Biologics gets EU GMP certification for biosimilars mfg units in Bengaluru
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Biocon
18 May 2020 , 11:33AM
Biocon: Q4FY2020 Results – Viewpoint - Q4FY2020 just a hiccup; Growth levers intact
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Biocon
15 May 2020 , 9:52AM
Biocon Q4FY20 weak performance; Results missed estimates.
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Biocon
12 May 2020 , 10:37AM
Subsidiary company Biocon Biologics limited, has received a certificate of GMP compliance from the EMA (European Medicines Agency) represented by the competent authority of Germany for its Biologics Drug Substance, facilities at Bengaluru. The plant manufactures drug substance of Pegfilgrastim and Recombinant Human Insulin and manufacturing related activities for Insulin Glargine and Insulin Aspart. This is positive as the certificate would enable the company to continue addressing the European markets.
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Biocon
8 May 2020 , 11:17AM
Receives an Establishment Inspection Report (EIR) from USFDA for pre approval and GMP inspection of its Small Molecules API Manufacturing Facility at Biocon Park SEZ, Bommansandra, Bengaluru, conducted between January 20 and January 24, 2020. At the conclusion of the inspection the agency had issued a Form 483, with five observations, which are being addressed by the Company. The EIR has been closed with a VAI status and hence is positive
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Biocon gets EIR report for Bengaluru small molecules API Plant
8 May 2020 , 10:22AM
Biocon's receives EIR for small molecules API Manufacturing Facility for Pre -Approval and GMP USFDA Inspection
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Biocon
29 Apr 2020 , 11:02AM
The company along with partner Mylan has launched Fulphila, a biosimilar of Neulasta (Pegfilgrastim) in Canada. Fulphila is approved by Health Canada and is indicated to decrease the incidence of infection in patients with non-myeloid malignancies receiving myelo-suppressive anti-neoplastic drugs. Positive as this would strengthen the lucrative biologics business for Biocon
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Biocon
16 Apr 2020 , 10:04AM
Biocon Biologics has received Establishment Inspection Report (EIR) from the USFDA for pre approval inspection (PAI) at two of its biologics manufacturing facilities in Bengaluru, inspected between 10-19 September 2019. Subsequent to the above inspection, Biocon Biologics has received approvals for the two products Trastuzumab (Drug Product) and Pegfilgrastim (Drug Substance) from the USFDA in 2019. The receipt of EIR indicates a successful closure of the inspection. Positive as this would aid the growth of the lucrative Biologics segment
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Biocon Biologics receives EIR from USFDA for 2 facilities
16 Apr 2020 , 10:00AM
Biocon Biologics receives EIR from USFDA for two manufacturing facilities, inspection stands closed
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Biocon
15 Apr 2020 , 10:14AM
The company along with Mylan has launched Fulphila, a biosimilar to Neulasta in Australia. The drug is approved by the Therapeutic Goods Administration for the treatment of cancer patients post Chemotherapy. Fulphila launch in Australia augurs well as it would boost the performance of the lucrative biologics segment.
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Biocon's Malaysia unit gets EIR from USFDA
1 Apr 2020 , 11:36AM
Biocon's Insulin manufacturing facility in Malaysia receives EIR from USFDA
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Biocon
1 Apr 2020 , 10:12AM
Subsidiary company Biocon Sdn Bhd, has received the Establishment Inspection Report (EIR) from the U.S. FDA for the Pre-Approval Inspection (PAI) of its Insulins manufacturing facility in Malaysia, for Insulin Glargine. The inspection done between Feb 10 and Feb 21, 2020 and has been closed with a “VAI” (Voluntary Action Indicated) classification in the EIR with three observations. The closing of the USFDA Inspection of Malaysia Facility is critical milestone achieved in towards developing and launching Insulin Glargine for US markets and hence is positive. The timeline set for insulin Glargine launch in the US markets in 1HCY2020.
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Biocon gets EIR from USFDA for manufacturing facility in Bengaluru
20 Mar 2020 , 12:59PM
Biocon receives the establishment inspection report (EIR) from US health regulator
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Biocon, Mylan win patent litigation against Sanofi in US
12 Mar 2020 , 12:26PM
Biocon & Mylan Win Patent Litigation Asserted by Sanofi for Insulin Glargine Device Patent in US
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Biocon
12 Mar 2020 , 10:23AM
Alongwith Mylan has won a patent litigation asserted by Sanofi for Insulin Glargine device patent in US – Positive as it removes overhang and clears the road for commercializing Semglee (Insulin Glargine)
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Biocon
11 Mar 2020 , 10:24AM
As per media news, the USFDA has accepted Biologics License Application (BLA) for Mylan – Biocon’s proposed biosimilar – Bevacizumab, which is a biosimilar version of the drug Avastin. The drug is indicated for no of types of cancer and specific eye diseases. The acceptance of the BLA is positive as it would further strengthen Biocon’s presence in the US markets in the biosimilars space.
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Biocon
9 Mar 2020 , 11:31AM
The USFDA has accepted Mylan’s Biologics License Application (BLA) for MYL – 14020, a proposed biosimilar to Avastin (Bevacizumab) for review under the 351 (k) pathway. The BLA seeks approval for first line and second line of treatments of patients with metastatic colorectal cancer in combination with fluorouracil based chemotherapy. Currently the drug is available in India and other developing nations. Positive If the company gets USFDA approval and would be the third biosimilar from the partnered portfolio in the US.
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USFDA accepts Biocon's biosimilar bevacizumab
9 Mar 2020 , 10:45AM
USFDA Accepts Biologics License Application (BLA) for Mylan and Biocon''s Proposed Biosimilar Bevacizumab for Review
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Biocon
27 Feb 2020 , 11:05AM
The USFDA conducted a post approval and GMP inspection at the company’s small molecules and API manufacturing facility between 20 February 2020 and 26 February 2020. The inspection ended with a form 483 and two observation which are procedural in nature. The management has stated that it would respond to the USFDA in a timely manner with a Corrective and Preventive Action plan. Receipt of 2 observations is negative.
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Biocon receives 2 USFDA observations for API unit in Bengaluru
27 Feb 2020 , 10:22AM
USFDA issues Form 483 with 2 observations to Biocon's Bengaluru API unit
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Biocon gets 3 USFDA observations for insulin facility in Malaysia
24 Feb 2020 , 12:24PM
Biocon's insulin manufacturing facility in Malaysia completes USFDA (PAI) Inspection
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Biocon
24 Feb 2020 , 10:51AM
The US FDA has done a pre-approval inspection of the insulin manufacturing facility of Biocon’s Malaysian subsidiary in between 10 February 2020 to 21 February 2020. The inspection ended with a form 483 with 3 observations, which are procedural in nature. The receipt of observations is negative.
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Biocon
27 Jan 2020 , 11:09AM
The USFDA has completed a Pre-approval inspection and GMP inspection of Biocon’s API manufacturing facility between 20 Jan 2020 to 24 Jan 2020. The inspection concluded with a form 483 being issued to Biocon with 5 observations and the management is confident of addressing the observations expeditiously. We would wait for further clarity on the observations received. Sentimentally Negative
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Biocon
27 Jan 2020 , 11:00AM
Biocon: Viewpoint - Growth levers intact
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Biocon falls on USFDA observations for Bengaluru unit
27 Jan 2020 , 10:51AM
Biocon's API manufacturing facility completes pre-approval and GMP USFDA inspection
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Biocon: Q3FY20 Results
24 Jan 2020 , 10:41AM
Biocon: Q3FY20 Results – Soft quarter; higher tax leads to PAT miss
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Biocon
23 Jan 2020 , 10:31AM
As per media news, the company has received US – FDA approval for Diabetes drug Dapagliflozin. Positive as it would strengthen the company’s product portfolio in the US
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Biocon completes pre-approval USFDA inspection with zero observations
20 Jan 2020 , 10:42AM
Biocon's oral solid dosage manufacturing facility completes pre-approval USFDA inspection with zero observations
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Biocon
20 Jan 2020 , 10:20AM
The US FDA completed a Pre-Approval Inspection of Oral solid Dosage Manufacturing facility of Biocon Pharma Limited, which is subsidiary of Biocon. The inspection was done between 13-17 Jan 2020 and concluded with zero observations. Positive
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True North to invest Rs. 536.25 crore in Biocon Biologics for 2.44% stake
6 Jan 2020 , 3:46PM
Deal values Biocon Biologics at USD 3 billion
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Biocon
6 Jan 2020 , 11:45AM
As per media news, leading Private equity fund – True North has acquired around 3% stake in Biocon Biologics India Ltd, a wholly owned subsidiary company of Biocon. The deal is valued at USD 100 mn (~RS 720 cr), valuing Biocon Biologics at around USD 3-3.5 bn (~ Rs 25,000 cr). This is the first round of larger USD 200-300 mn fund raising round that is expected to close before mid-2020. Biocon is also in talks with other global investors such as Temasek Holdings and UK Governments investment arm CDC, for subsequent rounds. This is positive for Biocon as the deal values Biocon Biologics at around Rs 25000 cr while Biocon’s market cap stands at around RS 36000 cr, thus pointing at a significant value unlocking opportunity. We have a positive stance on the stock.
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Biocon
18 Dec 2019 , 3:17PM
Biocon: Viewpoint - Biologics – A key Growth Engine
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Biocon
13 Dec 2019 , 11:37AM
Biocon and Equillium expand exclusive licensing agreement for Itolizumab drug in Australia and New Zealand market; positive read thru
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Biocon, Sun Pharma
6 Dec 2019 , 11:53AM
As per media sources, FDA Granted Approvals of Generic Fingolimod (Gilenya : Brand sales $1800mn) to HEC Pharm, Biocon, and Sun Pharma. Positive read thru.
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Biocon
3 Dec 2019 , 10:45AM
Biocon and Mylan has launched Trastuzumab biosimilar Ogivri in the US market. Ogivri, a biosimilar to Herceptin, has been co-developed by Biocon Biologics and Mylan and will be available in 150 mg and 420 mg strengths. Ogivri is used to treat breast cancer and gastric cancer. The company is targeting peak revenues of USD 70-100 mn from Ogiviri in US market (market size is USD 2 to 2.5 billion). It is the second biosimilar from the partnered portfolio of Biocon and Mylan being commercialised in the US. Biocon and Mylan aim to cross a revenue milestone of US $ 1 billion by FY2022 through biosimilars portfolio. Positive read thru.
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Biocon, Mylan launch cancer drug in US market
3 Dec 2019 , 10:14AM
Biocon, Mylan launch cancer drug in US market
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Biocon
27 Nov 2019 , 12:33PM
Has announced that Biocon and Mylan’s Supplemental Biologics License Application (sBLA) for Pegfilgrastim drug substance has been approved by the USFDA. The drug would be made at Biocon’s new Biologics manufacturing facility. The approval would enable the company to scale up capacity multi fold and address the growing market opportunities in the US and other global markets. The US FDA had conducted a per approval of this new drug substance manufacturing facility in September 10-September 19, 2019. Sentimentally positive read thru
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USFDA approves Biocon's sBLA for Pegfilgrastim New Manufacturing Facility
27 Nov 2019 , 10:40AM
Biocon, Mylan announces their supplemental Biologics License Application for Pegfilgrastim Drug
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Biocon gets EIR for Bengaluru's biologics drug products
5 Nov 2019 , 10:45AM
Biocon's Biologics drug products facility in Bengaluru receives EIR from USFDA
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Biocon
11 Oct 2019 , 10:39AM
Biocon Biologics, wholly owned subsidiary of Biocon enters into strategic licensing agreement with Just-Evotec Biologics for an early-stage, pre-clinical biosimilar asset – Long term Positive; Biocon Biologics will take this biosimilar asset through end-to-end development, IND filing, manufacturing and commercialization post-regulatory approval, under its own label in global markets.
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Biocon
3 Oct 2019 , 12:14PM
Biocon: Company with its partner Mylan Launch First Insulin Glargine Biosimilar (indicated for the treatment of type 1 diabetes,) Semglee, in Australia – Positive; Mylan and Biocon's insulin glargine biosimilar is currently approved in more than 40 countries around the world.
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Biocon stock to remain underpressure
27 Sep 2019 , 11:21AM
Biocon: USFDA’s Form 483 for Company’s manufacturing facility in Bengaluru highlights procedural lapses as well as lack of quality in manufacturing of products – Sentimentally negative; although all the 8 observations indicate procedural lapses, the stock to remain under pressure until resolved successfully.
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Biocon arm acquires 60,000 sq ft at TICEL Bio Park in Chennai
24 Sep 2019 , 10:34AM
Biocon Biologics expands its R&D footprint through acquisition
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Biocon gets Form 483 containing 8 observations
23 Sep 2019 , 11:29AM
USFDA Completes pre-approval inspection of two new Biocon biologics facilities in Bengaluru
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Biocon signs generic deal with Chinese pharma co
13 Sep 2019 , 1:38PM
Deal is positive and the collaboration can be extended to a broader portfolio in future
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Biocon's Malaysia arm gets GMP compliance certificate
22 Aug 2019 , 11:05AM
Biocon: Company’s Malaysia Insulin Glargine manufacturing facility has received EU-GMP certification – Positive, Successful audit provides boost to its capacity. Company’s biosimilar Insulin Glargine has been approved in over 60 countries and is commercialized in several key emerging markets
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Biocon arm gets GMP compliance certificate from European Medicines Agency
22 Aug 2019 , 10:21AM
Biocon's Malaysia insulin glargine manufacturing facility receives EU GMP certification
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Biocon gets Certificate of GMP compliance from EMA
14 Jun 2019 , 3:29PM
Biocon biologics facilities receive EU GMP certification
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Biocon, Mylan get Canadian nod for biosimilar cancer drug Ogivri
23 May 2019 , 10:21AM
Biocon: Company along with its partner Mylan gets approval from Health Canada for Ogivri (trastuzumab) – Positive; Mylan plans to launch the product this quarter & anticipates potentially being the first company to offer a trastuzumab biosimilar in Canada.
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Biocon retains economic interest in global commercialization
8 May 2019 , 12:41PM
Biocon: Biocon retains economic interest in global commercialization of Hulio, biosimilar adalimumab, drug in- licensed by Mylan (from Fujifilm Kyowa Kirin Biologics) and will gain a share of profits from global markets.
View: Positive for short term as the economic interest is protected. However we feel it is negative in long run for Biocon’s own drug (biosimilar adalimumab) under development (currently undergoing global clinical trials) as it may need more time to get approval for US & EU markets. Taking into consideration the competitive scenario (four players already in the market), Mylan has decided to extend the commercial rights from EU to Global markets.
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Biocon reports healthy Q4FY2019 earnings
26 Apr 2019 , 11:06AM
Biocon: Strong Q4FY2019 numbers (above street expectation but lower than our estimates); Bonus issue of 1:1 announced
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Biocon registers strong Q4FY2019 numbers
26 Apr 2019 , 11:01AM
Biocon: The company registered strong Q4FY2019 numbers with revenues and operating profit growing by 31% and 73%; Bonus issue of 1:1 is announce by the company - positive read through for the stock
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Biocon to consider issue of bonus shares
23 Apr 2019 , 10:42AM
Biocon to consider issuing of bonus shares on April 25 - Positive; Strong Q4FY19 result expected; We have a positive view on the stock and it is one of the preferred pick in the sector.
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Biocon board to mull bonus issue
23 Apr 2019 , 10:34AM
Board to consider and recommend a Final Dividend and Bonus issue
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Biocon sells and transfer drug substance business
3 Apr 2019 , 9:42AM
Biocon: Company sells and transfer drug substance business to its wholly owned biologics unit for Rs 33.3 crores. The company says the transfer of business will help in consolidation of the business – Neutral; No business or financial impact as the transfer is internal; Biocon continues to one of our preferred pick in the sector.
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Biocon gets FDA Form 483 with two observations
13 Mar 2019 , 11:27AM
Biocon: As per media reports, company has received FDA Form 483 with two observations – Sentimentally negative.
First observation stated procedures designed to prevent microbiological contamination is not being followed. Second observation stated that written records of investigations into unexplained discrepancies don’t have adequate conclusion.
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Biocon slips on FDA concerns
7 Mar 2019 , 10:35AM
Biocon falls to Rs. 608.5, after USFDA observations on Bengaluru facility
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USFDA concludes pre-approval inspection of Biocon’s Bengaluru facility
7 Mar 2019 , 9:20AM
Biocon: USFDA concludes pre-approval inspection of Biocon’s Bengaluru facility with issuance of Form 483
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Biocon Q3FY2019 result above expectation
25 Jan 2019 , 10:01AM
Biocon posts Q3 net profit at Rs.211.4 crore for the Quarter ended December 31, 2018
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Biocon biosimilar Trastuzumab gets nod in European Union
19 Dec 2018 , 9:56AM
Biosimilar Trastuzumab Co-Developed by Biocon receives approval in the European Union
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Biocon's Bengaluru unit completes USFDA inspection
12 Nov 2018 , 12:38PM
Biocon's Bengaluru unit completes United States Food and Drug Administration (USFDA) Inspection with No 483 observations
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Biocon Q2FY2019: Strong performance
26 Oct 2018 , 1:09PM
Biocon reports a strong revenue growth of 36.4% at Rs 1,321 crore
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Biocon Q2FY2019: Strong performance
26 Oct 2018 , 10:19AM
Biocon reports a strong revenue growth of 36.4% at Rs. 1,321 crore
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USFDA completes inspection at Biocon’s Bangalore facility
24 Sep 2018 , 11:56AM
Biocon received positive opinion from European Medicines Agency’s (EMA) Committee for recommending approval of bio-similar product ‘Fulphila; Positive opinion will now be considered by the European Commission and decision on approval is expected by Nov. 2018; Positive for Biocon; USFDA completed their inspection at Biocon’s Bangalore facility with no Form 483 being issued.
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Biocon: Scaling new heights
30 Jul 2018 , 12:54PM
Biocon: Scaling new heights; Potential value unlocking; Maintain positive stance
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Biocon Q1FY2019 profit beats estimates
27 Jul 2018 , 10:40AM
Biocon Q1 net profit rises by 47.8% at Rs1124 cr for the Quarter ended June 30, 2018
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Biocon gets EU GMP certification
5 Jul 2018 , 10:30AM
Biocon receives EU GMP certification for its sterile manufacturing facility in Bangalore
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Biocon company receives EU GMP certification
5 Jul 2018 , 9:30AM
Positive read through for Biocon
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Biocon, Mylan gets USFDA nod for Neulasta
5 Jun 2018 , 11:58AM
Biocon announces that USFDA approves Mylan's FulphilaTM, a biosimilar to Neulasta®, co-developed with Biocon
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Biocon receives USFDA approval for Fulphila
5 Jun 2018 , 10:57AM
Positive read through for Mylan and Biocon.
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Biocon has target action date for biosimilar pegfilgrastim
4 Jun 2018 , 9:46AM
Stock to remain in focus.
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Company’s Bangalore plant had received 483 observations
18 May 2018 , 10:43AM
Positive for Biocon
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Biocon Q4FY18 shows strong performance
27 Apr 2018 , 11:53AM
Strong performance , profit beat led by higher other income
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Biocon up as Mylan enters in pact with Fujifilm
12 Apr 2018 , 11:23AM
Biocon rises by 3% at Rs629.55, after company announces that it along with Mylan seek to accelerate introduction of adalimumab biosimilar in European Union
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Biocon, Mylan seek to introduce adalimumab biosimilar
12 Apr 2018 , 9:46AM
We have a positive view on the stock and it is one of our preferred pick in the sector.
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USFDA completes pre-approval inspection of Malaysia plant of Biocon
21 Feb 2018 , 1:11PM
Negative read through for Biocon as USFDA issues Form 483 with 6 observations
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European Medical Agency in favor of Biocon's insulin glargine application
29 Jan 2018 , 9:34AM
Biocon gets a positive opinion from European Medical Agency (EMA) for Insulin glargine application, Semglee (partnered with Mylan).
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Biocon reports results above expectations in Q3FY18
25 Jan 2018 , 2:57PM
We have positive view on stock and it is one of our preferred pick.
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Biocon scaling new heights
22 Jan 2018 , 12:18PM
Maintain positive view for Biocon as it delivers delivers strong 38.3% returns in less than two months.
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Biocon announces a global partnership with Sandoz
19 Jan 2018 , 9:14AM
We have a positive view on the stock and it is one of our preferred pick in the large-cap pharma space.
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Biocon gives a green light for transfer of biosimilar business through slump sale to Biocon Biologics
8 Dec 2017 , 12:52PM
Investors have taken a keen interest in Biocon post approval from USFDA for biosimilar drug through Mylan.
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Biocon board approves transfer of Biosimilars business
8 Dec 2017 , 9:11AM
Positive for long term as the company plans to monetize the opportunity by listing the subsidiary in future.
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Biocon's first biosimilar trastuzumab gets USFDA nod
5 Dec 2017 , 11:30AM
Biocon: Maintain Positive view. We had initiated a viewpoint on Biocon Limited (Biocon) on November 23, 2017, at the CMP of Rs. 412 (as we highlighted that H2FY2018 will be eventful as many triggers are lined up), and expected 20% upside in six months. One of the key triggers, i.e. approval of biosimilar trastuzumab has led to a sharp jump in the stock price, giving 25% returns in just 10 days.
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Biocon and Mylan Inc receive USFDA nod for Ogivir
4 Dec 2017 , 12:47PM
Big positive for Biocon as the approval puts it into league of global biosimilar players; Herceptin had US sales of $ 2 billion.
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Biocon and Mylan Inc receive USFDA nod for Ogivir
4 Dec 2017 , 8:49AM
Big positive for Biocon as the approval puts it into league of global biosimilar players; Herceptin had US sales of $ 2 billion; We have a positive view on the stock.
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EMA accepts MAA for Biocon and Mylan
1 Dec 2017 , 9:13AM
Positive impact on Biocon stocks as EMA accepts MAA
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Biocon receives EIR from USFDA
24 Nov 2017 , 10:51AM
Biocon: Regulatory hurdles cleared, H2FY18 will be eventful.
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Biocon introduces cancer drug in India; stk up
23 Nov 2017 , 1:43PM
Biocon rises by 3% to Rs419.72, after company announces that it has launch a cancer drug in India
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Biocon gets Establishment Inspection Report from USFDA
20 Nov 2017 , 10:16AM
Positive for Biocon as FDA has classified the outcome as Voluntary Action Indicated (VAI) and the EIR states that the inspection is closed.
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Biocon gets Establishment Inspection Report from USFDA
20 Nov 2017 , 8:58AM
Positive for Biocon as FDA has classified the outcome as Voluntary Action Indicated (VAI) and the EIR states that the inspection is closed.
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Biocon's partner Mylan Inc resubmits application with European medicine agency
7 Nov 2017 , 8:55AM
Positive for Biocon as it has completed corrective measures post audit and expects it to be verified once Banglore facility is re-inspected.
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Biocon reports disappointing Q2FY2018 numbers
27 Oct 2017 , 10:27AM
Factors affecting earning performance were plant modifications undertaken to comply regulatory requirements led to production disruptions, regulatory and tender delays in some emerging markets for biosimilars business, Malaysia facility costs and pricing pressures in API’s.
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Biocon up as USFDA issues CRL for proposed biosimilar
10 Oct 2017 , 12:16PM
Biocon rises by 5% to Rs361, after US drug regulator issues complete response letter to a proposed biosimilar being developed jointly by Biocon and Mylan
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USFDA issues CRL for Proposed Biosimilar Pegfilgrastim
10 Oct 2017 , 10:03AM
USFDA issues Complete Response Letter (CRL) for Proposed Biosimilar Pegfilgrastim. The CRL relates to the pending update of the Biologics License Application (BLA) with certain data from facility requalification activities post recent plant modifications – Negative
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Biocon’s Neulasta has USFDA TAD 9th October 2017
9 Oct 2017 , 11:15AM
Biocon’s biosimilar Neulasta (pegfilgrastim - $ 4.6 bn global market size / innovator sales) has USFDA Target Action Date (TAD) on 9th October 2017 (late evening in India) - Biocon to remain in focus till outcome of USFDA is known (If the drug is approved, it may indicate early resolution of 483 observations at Bangalore facility).
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USFDA reports no observations for Biocon's API facility
19 Sep 2017 , 8:59AM
USFDA completes inspection of Active Pharmaceutical Ingredients (API) manufacturing facility at Visakhapatnam with no observations – Positive for Biocon.
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USFDA extends Biocon's Trastuzumab review application deadline
31 Aug 2017 , 11:54AM
Biocon said that the USFDA has notified its partner Mylan that it will take more three months to review application for Trastuzumab 351(K) - Neutral Impact on stock.
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Biocon withdraws Trastuzumab and pegfilgrastim applications
16 Aug 2017 , 11:58AM
Biocon withdraws Trastuzumab and pegfilgrastim application - Negative for Biocon;
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Biocon drops after observations from USFDA
4 Aug 2017 , 11:07AM
Biocon slips over 9% to Rs341, after USFDA issues a form 483 with 10 observations for its Bengaluru facility
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USFDA issues form 483 to Biocon's Bangalore injectable facility
4 Aug 2017 , 8:49AM
Biocon: Form 483 for Bangalore injectable facility; Negative read thru.
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Biocon surges after favourable vote for new drug
14 Jul 2017 , 11:39AM
Biocon rises over 10% to Rs404, as US health regulator’s ODAC recommends approval for the company's proposed biosimilar Trastuzumab, indicated for breast cancer treatment
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Biocon hardens ahead of USFDA meet
12 Jul 2017 , 2:08PM
Biocon rises over 12% to Rs363, ahead of the regulator meeting to discuss trastuzumab filing done by Mylan
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Biocon drops as French regulator finds lapses at Bengaluru plant
10 Jul 2017 , 12:38PM
Biocon slips over 9% to Rs305, on reports that the French health regulator found lapses in quality compliance at its Bangalore plant during a March inspection
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Biocon fixes record date for bonus issue: stk up
8 Jun 2017 , 10:52AM
Biocon rises over 2% to Rs1018.9, after the company fixed June 17, 2017 as the record date for issue of bonus shares