Biocon Biologics Signs Settlement And License Agreement To Commercialize Biosimilar Aflibercept Worldwide

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, announced today 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.

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.

Molecule Information
YESAFILI, a biosimilar Aflibercept, 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).

About Biocon Biologics Limited
Biocon Biologics Limited, a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its ‘lab to market’ capabilities to serve over 6.3 million patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes.

Biocon Biologics has commercialized 10 biosimilars from its portfolio which are addressing the patients’ needs in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 20+ biosimilar assets across diabetology, oncology, immunology, ophthalmology, bone health and other non-communicable diseases. The Company has many ‘firsts’ to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). The meaningful progress on ESG parameters has been recognized with the Company’s inclusion in the S&P Global Sustainability Yearbook in 2025. For more information, visit www.bioconbiologics.com.

Biocon Limited, publicly listed in 2004, is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the U.S., Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. For more information, visit www.biocon.com.