Biocon Biologics Ltd (BBL), a comprehensive global biosimilars firm and a subsidiary of Biocon Ltd, has reached new settlement and license agreements with Regeneron and Bayer.

These agreements grant Biocon Biologics the necessary clearance to globally commercialize Yesafili, its biosimilar Aflibercept (40mg/ml). This follows a previous agreement that covered the United States and Canada.

Yesafili is a vascular endothelial growth factor (VEGF) inhibitor prescribed for a variety of ophthalmology conditions.

By executing this agreement, all pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed. The resolution enables the launch of Yesafili in the United Kingdom in January 2026 and in the remaining settled countries starting in March 2026, or potentially sooner under certain conditions. The specific financial and legal terms of the settlement remain confidential.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said, “This settlement paves the way for Biocon Biologics to make available our biosimilar Aflibercept globally. This milestone expands our presence in the ophthalmology therapeutic area as we work closely with healthcare systems to increase access to patients everywhere.”

The European Commission (EC) and the Medicines & Healthcare products Regulatory Agency (MHRA) have previously approved YESAFILI.

Biocon Biologics secured a market entry for its biosimilar Aflibercept for the U.S. in April 2025, for second half of calendar year 2026 or earlier in certain circumstances. YESAFILI was launched in Canada earlier this year and the market entry was secured for Canada in March 2024.