Product Launch in US - Biocon Ltd

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Biocon Biologics Secures Market Entry Date for Yesafili™ , an Interchangeable Biosimilar to Eylea®, in the U.S. BIOCON Ltd announced today a settlement and license agreement with Regeneron that clears the way to commercialize Yesafili™ (aflibercept-jbvf), an interchangeable* biosimilar aflibercept, in the United States. YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product EYLEA® (aflibercept). Biocon Biologics and Regeneron executed the settlement agreement to dismiss the pending appeal at the United States Court of Appeals for the Federal Circuit (USCAFC) of patent US11084865 (‘865 patent) and the pending litigation at the U.S. District Court for the Northern District of West Virginia, Clarksburg Division. This agreement enables the Company to launch in the United States in the second half of calendar year 2026 or earlier in certain circumstances. The terms of the settlement are confidential.