Biocon Biologics Secures Global Rights to Commercialize Biosimilar Aflibercept

Biocon Biologics has signed a global settlement and license agreement with Regeneron and Bayer, clearing the way for worldwide commercialization of its biosimilar Aflibercept (40 mg/ml), marketed as YESAFILI. The agreement, which follows an earlier U.S. and Canada settlement, resolves all pending litigation and enables phased market launches across Europe and other international markets beginning in early 2026.

Global Market Access Milestones
Under the agreement, Biocon Biologics plans to launch YESAFILI in the United Kingdom in January 2026, followed by other countries where it has been settled from March 2026 or earlier, under certain conditions. Regulatory approvals have already been secured from the European Commission and the UK’s MHRA. At the same time, U.S. market entry is planned for the second half of 2026, and Canada has already seen a successful launch.

Strengthening Ophthalmology Portfolio
YESAFILI is a VEGF inhibitor indicated for multiple retinal disorders, including wet age-related macular degeneration, diabetic macular oedema, and retinal vein occlusion. The global settlement significantly expands Biocon Biologics’ ophthalmology footprint, supporting its strategy to improve patient access to high-quality biosimilars and partner with healthcare systems to address unmet needs worldwide.