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Biocon Biologics Ltd, a subsidiary of Biocon Ltd, secured U.S. FDA approval for Yesafili, an interchangeable biosimilar to Eylea (aflibercept). Yesafili is designed to treat ophthalmological conditions, including neovascular age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization.
The company reported, the approval follows previous authorisations in Europe and the United Kingdom in 2023, where Yesafili was the first biosimilar aflibercept to be approved. The company set a launch date for Yesafili in Canada by July 1, 2025, as stipulated by a settlement agreement.
Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd.,said, ““The FDA approval of YESAFILI (aflibercept) 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. YESAFILI is approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. This approval builds on our successful track record of bringing the first interchangeable insulin, SEMGLEE, the first biosimilar Trastuzumab, OGIVRI, and the first biosimilar Pegfilgrastim, FULPHILA, to patients in the United States.”
The shares were up by 1.33% to ₹308.75 at 10.40 am on the BSE.
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