Biocon Biologics Secures Global Settlement for Aflibercept Biosimilar, Enabling Worldwide Commercialization
Key Insights
Biocon Biologics (search) signed a settlement and license agreement with Regeneron and Bayer to commercialize biosimilar Aflibercept (Yesafili) worldwide, following an earlier settlement for U.S. and Canadian markets.
The agreement enables launch of Yesafili in the United Kingdom in January 2026 and other settled countries in March 2026, expanding access to this VEGF (search) inhibitor for multiple ophthalmology conditions.
Yesafili has received approval from the European Commission and UK MHRA, and is already launched in Canada with U.S. market entry secured for the second half of 2026.
Biocon Biologics (search) Ltd has announced a comprehensive settlement and license agreement with Regeneron and Bayer that clears the path for global commercialization of its biosimilar Aflibercept, marketed as Yesafili. The December 13, 2025 agreement covers Europe and the rest of the world, building upon an earlier settlement that addressed the U.S. and Canadian markets.
Global Market Access Secured
The settlement enables Biocon Biologics (search) to launch Yesafili in the United Kingdom in January 2026, followed by launches in other settled countries in March 2026, or earlier under certain circumstances. As part of the agreement, all pending litigation among Biocon Biologics, Regeneron, and Bayer has been dismissed, with other terms of the settlement remaining confidential.
Yesafili is a vascular endothelial growth factor (VEGF (search)) inhibitor indicated for treating multiple ophthalmology conditions, including neovascular (wet AMD) age-related macular degeneration (search), visual impairment due to macular oedema secondary to retinal vein occlusion (search) (branch RVO or central RVO), diabetic macular oedema (search) (DME), and myopic choroidal neovascularisation (search) (myopic CNV).
Regulatory Approvals and Market Timeline
The European Commission (EC) and the UK Medicines & Healthcare products Regulatory Agency (MHRA) have previously approved Yesafili. The biosimilar has already been launched in Canada earlier this year, with market entry secured in March 2024. For the U.S. market, Biocon Biologics (search) secured market entry in April 2025, targeting the second half of calendar year 2026.
"This settlement paves the way for Biocon Biologics (search) to make available our biosimilar Aflibercept globally," said Shreehas Tambe, CEO & Managing Director of Biocon Biologics. "This milestone expands our presence in the ophthalmology therapeutic area as we work closely with healthcare systems to increase access to patients everywhere."
Company Performance and Portfolio
Biocon Biologics (search), a subsidiary of Biocon Limited, operates as a fully integrated global biosimilars company serving over 6.3 million patients across 120+ countries. The company has commercialized 10 biosimilars from its portfolio and maintains a pipeline of 20+ biosimilar assets across diabetology, oncology, immunology, ophthalmology, bone health and other non-communicable diseases.
On a consolidated basis, Biocon reported net profit of Rs 84.50 crore in Q2 September 2025 compared to a net loss of Rs 16 crore in Q2 September 2024. Net sales rose 20.24% year-over-year to Rs 4262.50 crore in Q2 September 2025, reflecting the company's strong financial performance as it expands its global biosimilars portfolio.