New Delhi: Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE: 532523, NSE: BIOCON), has announced a landmark settlement and license agreement with Regeneron and Bayer for biosimilar Aflibercept (40mg/ml) across Europe and the rest of the world. This follows an earlier settlement covering the United States and Canada, effectively clearing the way for Biocon Biologics to commercialize its biosimilar product Yesafili® worldwide.
YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat multiple ophthalmology conditions including neovascular (wet AMD) age-related macular degeneration, macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV).
Under the agreement, Biocon Biologics, Regeneron, and Bayer have dismissed all pending litigation. The settlement enables Biocon Biologics to launch YESAFILI in the United Kingdom in January 2026, followed by other settled countries in March 2026 or earlier under certain circumstances. Other terms of the settlement remain confidential.
Shreehas Tambe, CEO & Managing Director of Biocon Biologics, stated: “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 also secured market entry for its biosimilar Aflibercept in the U.S. in April 2025, with launch expected in the second half of 2026 or earlier. YESAFILI was launched in Canada earlier this year, following market entry approval in March 2024.
This global settlement marks a significant milestone for Biocon Biologics, reinforcing its commitment to expanding access to affordable biosimilars and strengthening its footprint in the ophthalmology segment worldwide.
