EC greenlight for Biocon's aflibercept biosimilar

Following a favorable recommendation form the European Medicines Agency’s advisory committee on July, the European Commission (EC) has now granted marketing authorization in the European Union (EU) for Indian drugmaker Biocon’s (BSE: 532523) Yesafili, a biosimilar of Bayer’s (BAYN: DE) Eylea (aflibercept).

Ophthalmic drug Yesafili, is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular edema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is highly similar to the reference product Eylea. Data shows that Yesafili has comparable quality, safety, and efficacy to Eylea, noted Biocon.

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.