Biocon Biologics Obtains FDA Approval for Biosimilar Aflibercept 'Yesafili™' in U.S. Ophthalmology Market

Biocon Biologics, a subsidiary of Biocon Ltd, announced the US FDA approved their first-to-file application for 'Yesafili™' (aflibercept-jbvf), an interchangeable biosimilar aflibercept. Yesafili, a vascular endothelial growth factor (VEGF) inhibitor for treating ophthalmology conditions, is comparable to the reference product EYLEA®. It's the first interchangeable biological product approved by the FDA for Biocon Biologics, marking their entry into the ophthalmology therapeutic area in the US. This follows successful approvals in Europe and the United Kingdom. The company intends to launch in Canada by July 1, 2025.