Corporate News     24-Jul-23
Biocon Biologics receives EMA CHMP's positive opinion for YESAFILI®, an aflibercept biosimilar
Biocon Biologics, a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the European Medicines Agency's Commitee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of YESAFILI®, an aflibercept biosimilar.

YESAFILI®, an ophthalmology product, is intended for the treatment of 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). It is highly similar to the reference product Eylea® (aflibercept). Data shows that YESAFILI® has comparable quality, safety, and efficacy to Eylea®.

The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected by the end of September 2023.

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