Biocon Biologics signs settlement, license agreement to commercialize biosimilar Aflibercept worldwide
Bengaluru: Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has announced a new settlement and license agreement with Regeneron and Bayer for biosimilar Aflibercept (40mg/ml) in Europe and the rest of the world, which follows an earlier settlement covering the United States and Canada.
This agreement clears the way for Biocon Biologics to commercialize Yesafili, a biosimilar Aflibercept (40mg/ml), in all countries worldwide.
YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor used to treat multiple ophthalmology conditions.
It is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).
Biocon Biologics, Regeneron and Bayer executed the agreement to dismiss all pending litigation. This agreement enables the Company to launch YESAFILI in the United Kingdom in January 2026 and in the rest of the settled countries in March 2026 or earlier in certain circumstances. The other terms of the settlement are 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.
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