Biocon Limited has informed the Exchange regarding a press release dated April 15, 2025, titled "Biocon Biologics Secures Market Entry Date for Yesafili , an Interchangeable Biosimilar to Eylea?, in the U.S.".
BIOCON · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Awaiting price reaction for this filing.
Biocon's subsidiary Biocon Biologics has signed a settlement and license agreement with Regeneron, clearing all pending patent litigation related to Yesafili (aflibercept-jbvf), an interchangeable biosimilar to Eylea. Under the deal, the pending appeal at the U.S. Court of Appeals and the district court case in West Virginia have been dismissed. This allows Biocon Biologics to launch Yesafili in the United States in the second half of calendar year 2026, or earlier under certain conditions. Yesafili is a VEGF inhibitor used to treat eye conditions like wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion, and was already approved by the U.S. FDA in May 2024. Biocon Biologics has also secured a separate Canadian settlement with Bayer and Regeneron, allowing launch there no later than July 1, 2025. The company says Yesafili will be among the first interchangeable biosimilars to Eylea in the U.S. and marks its strategic entry into ophthalmology.
Positive for shareholders: the settlement removes a major legal overhang, secures a clear U.S. launch pathway for a high-value ophthalmology product, and strengthens Biocon Biologics' biosimilar pipeline. Investors may view this as a meaningful revenue catalyst from FY27 onwards, though near-term financials remain unchanged since commercial sales are still over a year away.