Lupin receives positive CHMP opinion for Biosimilar Ranibizumab

Global pharma major Lupin announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has
adopted a positive opinion recommending marketing authorization for its biosimilar ranibizumab, RanluspecTM, for both vial and pre-filled syringe presentations.

The positive CHMP opinion is based on a demonstration of similarity to the reference product, including an analytical similarity assessment and a 600-patient global phase III clinical trial in patients with Neovascular AMD, conducted in the US, EU, Russia, and India.