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First Biosimilar Approval Alert: Biocon Biologics’ Yesafili® Biosimilar to Regeneron’s Eylea® (aflibercept) Approved by EC

Sep 20, 2023

Biocon Biologics announced that Yesafili®, its biosimilar to Regeneron’s Eylea® (aflibercept), has received marketing approval from the European Commission (EC).  It was approved to treat various ophthalmic conditions such neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

This approval follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)  positive opinion for Yesafili® on 21 July 2023.