In a strategic move that strengthens its position in the global biosimilars market, Biocon Biologics has entered into a settlement and licensing agreement with U.S.-based biotechnology company Regeneron. This agreement will pave the way for its aflibercept biosimilar, Yesafili, to debut in the U.S. market by the second half of 2026.
Yesafili, a vascular endothelial growth factor (VEGF) inhibitor, is a biosimilar to the widely used ophthalmology drug Eylea (aflibercept). It is indicated for treating a range of vision-related disorders including wet age-related macular degeneration (AMD), diabetic macular edema, and retinal vein occlusion.
Legal Resolution Clears Commercial Path
The agreement brings to a close ongoing legal disputes in the U.S. Court of Appeals for the Federal Circuit and the District Court for the Northern District of West Virginia. Though the financial specifics remain confidential, Biocon confirmed that the resolution grants them the right to introduce Yesafili in the U.S. market by H2 2026—or earlier under specified conditions.
USFDA Approval Adds Strategic Edge
Yesafili received the U.S. Food and Drug Administration’s (USFDA) nod as an interchangeable biosimilar in May 2024. This designation not only recognizes the drug’s efficacy and safety parity with the reference product but also allows for pharmacy-level substitution—marking a significant competitive advantage.
Shreehas Tambe, CEO and Managing Director of Biocon Biologics, described the agreement as a “milestone” for the company. “This settlement clears the path for Biocon Biologics to be among the first to bring a reliable, high-quality aflibercept biosimilar to patients and healthcare providers in the U.S.,” he said, noting that it affirms the company’s scientific capabilities and marks its formal entry into the U.S. ophthalmology market.
Canadian Market Entry Also Secured
In parallel, Biocon Biologics also announced a separate settlement with Bayer Inc. and Regeneron in Canada, which enables the company to launch Yesafili in the Canadian market by no later than July 1, 2025.
Market Response and Outlook
Following the announcement, Biocon Ltd. shares rose by 3.29%, closing at ₹326.95 on the Bombay Stock Exchange. The development is expected to significantly bolster Biocon Biologics’ international portfolio and revenue prospects as it penetrates one of the world’s largest pharmaceutical markets.
The entry of Yesafili into North America—both in the U.S. and Canada reflects a broader industry trend of biosimilar adoption, especially in high-cost therapeutic segments like ophthalmology. With interchangeable biosimilars gaining traction in regulated markets, Biocon Biologics’ timely strategic positioning could make it a key player in this evolving space.
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