Biocon Ltd. shares surged 3% after its subsidiary, Biocon Biologics Ltd., announced a major breakthrough in the U.S. market with the confirmed entry of Yesafili™ (aflibercept-jbvf)—an interchangeable biosimilar to the blockbuster ophthalmology drug Eylea®.
The company reached a settlement and license agreement with Regeneron, enabling a U.S. commercial launch in the second half of 2026, or sooner under specific conditions. The deal resolves all U.S. litigation concerning the ‘865 patent, clearing the legal path for Yesafili’s launch.
Yesafili™ is designed to treat several retinal diseases, including neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy. The biosimilar demonstrated no clinically meaningful differences compared to Eylea® in efficacy, safety, pharmacokinetics, and immunogenicity, based on results from a Phase 3 clinical trial involving patients with diabetic macular edema. The FDA’s designation of Yesafili as an interchangeable biosimilar highlights Biocon Biologics’ entry into the U.S. ophthalmology market, expanding its global footprint in specialty biologics.
Alongside progress in the U.S., Biocon Biologics has also reached a similar agreement in Canada, with commercial launch set no later than July 1, 2025. With nine biosimilars already launched globally and a strong pipeline spanning oncology, immunology, diabetology, and now ophthalmology, Biocon Biologics continues to strengthen its leadership in the global biosimilars market.
Biocon shares opened at ₹321.00 today, hitting a high of ₹327.00 and a low of ₹319.70 during the session. The stock is trading well above its 52-week low of ₹259.85 but still below the 52-week high of ₹404.70.
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