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FDA Approves Biocon and Biogen Biosimilars for Regeneron's Eylea

May 20, 2024, 08:10 PM

The U.S. Food and Drug Administration (FDA) has approved two biosimilar versions of Regeneron Pharmaceuticals' blockbuster eye drug Eylea on Monday. The biosimilars, developed by Biocon Biologics and Biogen, are the first-ever biosimilar versions of Eylea to receive FDA clearance. This approval facilitates interchangeability without a doctor's prescription and does not require switching studies as part of the approvals. The launch dates for these therapies remain uncertain, but the approval marks a significant development for Regeneron as it faces increasing competition.