Biocon Biologics has reached a settlement and license agreement with Regeneron and Bayer, enabling the commercialization of its biosimilar Aflibercept in Europe and worldwide. This agreement allows Biocon Biologics to launch Yesafili®, its biosimilar Aflibercept, across global markets, with launches planned for the United Kingdom in January 2026 and other settled countries by March 2026 or earlier. The settlement dismisses all pending litigation.
Global Commercialization Agreement
Biocon Biologics Ltd (BBL) has announced a new settlement and license agreement with Regeneron and Bayer, clearing the path for the global commercialization of its biosimilar Aflibercept. This agreement builds upon a previous settlement covering the United States and Canada.
Yesafili® Launch Timeline
The agreement enables Biocon Biologics to launch Yesafili®, a biosimilar Aflibercept (40mg/ml), in all countries. Plans are in place to launch in the United Kingdom in January 2026, with subsequent launches in other settled countries slated for March 2026 or earlier, under certain circumstances. The specific terms of the settlement remain confidential.
Biosimilar Aflibercept Details
YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor used to treat multiple ophthalmology conditions.
Executive Commentary
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.”
Regulatory Approvals
YESAFILI has secured approval from both the European Commission (EC) and the Medicines & Healthcare products Regulatory Agency (MHRA).
Previous Market Entries
Biocon Biologics previously secured market entry for its biosimilar Aflibercept for the U.S. in April 2025, and also launched in Canada with market entry secured in March 2024.
Targeted Conditions
YESAFILI is intended for the treatment of several eye disorders, including neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion, visual impairment due to diabetic macular edema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV).
Source: BSE
