Biocon Biologics, a subsidiary of Biocon Ltd, announced the FDA has approved the company's first-to-file application for Yesafili, an interchangeable biosimilar aflibercept. YESAFILI is a biosimilar of its reference product EYLEA. YESAFILI is intended for the treatment of neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation.
Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said: "The FDA approval of YESAFILI as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics marking our entry into Ophthalmology, a new therapeutic area in the United States."
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