Biocon Biologics Ltd (BBL), a wholly owned subsidiary of Biocon Ltd (BSE: 532523, NSE: BIOCON), has entered into a settlement and licensing arrangement with Regeneron and Bayer covering Europe and other international markets for its biosimilar Aflibercept (40 mg/ml). This agreement follows a previously announced settlement for the United States and Canada and removes remaining legal barriers to global commercialization.
With this development, Biocon Biologics is now positioned to commercialize YESAFILI®, its biosimilar Aflibercept, across all global markets. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor used in the treatment of several retinal disorders. As part of the agreement, all ongoing litigation between the parties has been withdrawn. Financial and commercial terms of the settlement remain confidential.
The agreement allows Biocon Biologics to introduce YESAFILI in the United Kingdom beginning January 2026, with launches in other covered markets planned for March 2026 or earlier under certain conditions.
Shreehas Tambe, CEO and Managing Director of Biocon Biologics, stated, “This agreement represents an important step forward in making our biosimilar Aflibercept available to patients worldwide. It strengthens our position in ophthalmology and reinforces our commitment to expanding patient access through collaboration with healthcare systems globally.”
YESAFILI has already received regulatory approval from both the European Commission and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA). In the United States, Biocon Biologics secured market entry for biosimilar Aflibercept in April 2025, with commercialization planned for the second half of 2026 or earlier under specific circumstances.
The product was launched in Canada earlier this year following market entry approval in March 2024. YESAFILI is indicated for the treatment of neovascular (wet) age-related macular degeneration, visual impairment caused by macular edema secondary to retinal vein occlusion (branch or central), diabetic macular edema, and myopic choroidal neovascularization.
