Biocon Biologics secures global settlement for biosimilar Aflibercept

Biocon Biologics Ltd (BBL) has finalized a new settlement and license agreement with Regeneron and Bayer for its biosimilar Aflibercept (40mg/ml), branded as Yesafili®. This agreement covers Europe and the rest of the world, following an earlier settlement for the United States and Canada, clearing the path for global commercialization.

The agreement resolves all pending litigation and allows BBL to launch Yesafili® in the United Kingdom by January 2026, and in other settled countries by March 2026 or earlier under specific conditions. Yesafili®, a vascular endothelial growth factor (VEGF) inhibitor, treats various ophthalmology conditions, including wet AMD and diabetic macular oedema. The European Commission (EC) and the MHRA have already approved Yesafili®.

Biocon Biologics previously secured U.S. market entry for Yesafili® for the second half of calendar year 2026 or earlier, and launched the product in Canada in March 2024. This global settlement expands Biocon Biologics' presence in the ophthalmology therapeutic area, aiming to increase patient access worldwide.