Biocon Biologics Secures Global License for Biosimilar Aflibercept
Filing Summary
Biocon Biologics Ltd, a subsidiary of Biocon Ltd, has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of biosimilar Aflibercept, branded as Yesafili®, worldwide. This agreement allows Biocon Biologics to launch Yesafili in the United Kingdom in January 2026 and in other settled countries by March 2026. The European Commission and the Medicines & Healthcare products Regulatory Agency have approved Yesafili. The agreement resolves all pending litigation between the parties. Financial terms of the agreement remain confidential.
Biocon Biologics Ltd, a subsidiary of Biocon Ltd, has entered into a settlement and license agreement with Regeneron and Bayer. This agreement grants Biocon Biologics the rights to commercialize the biosimilar Aflibercept, branded as Yesafili®, globally. The agreement follows a previous settlement covering the United States and Canada.
The financial terms of the agreement between Biocon Biologics, Regeneron, and Bayer are confidential. The agreement resolves all pending litigation related to the biosimilar Aflibercept. This settlement enables Biocon Biologics to proceed with the commercialization of Yesafili in various international markets.
The scope of the agreement allows Biocon Biologics to launch Yesafili, a vascular endothelial growth factor (VEGF) inhibitor, in the United Kingdom in January 2026. The product will be available in other settled countries by March 2026, with the possibility of earlier launches under certain conditions. Yesafili is used to treat multiple ophthalmology conditions, including neovascular age-related macular degeneration and diabetic macular oedema.
The European Commission and the Medicines & Healthcare products Regulatory Agency have previously approved Yesafili. Biocon Biologics secured market entry for its biosimilar Aflibercept in the U.S. in April 2025, with plans for availability in the second half of 2026. Yesafili was launched in Canada earlier in 2025, following market entry secured in March 2024.
The agreement involves Biocon Biologics, Regeneron, and Bayer, with the latter two companies previously holding rights to Aflibercept. The collaboration allows Biocon Biologics to expand its presence in the ophthalmology therapeutic area and increase access to biosimilars globally.
Biocon Biologics Limited is a global biosimilars company focused on transforming healthcare by providing affordable access to high-quality biosimilars. The company serves over 6.3 million patients across more than 120 countries, leveraging its integrated capabilities from lab to market. Biocon Biologics has commercialized 10 biosimilars and has a pipeline of over 20 biosimilar assets across various therapeutic areas.
Biocon Limited, publicly listed since 2004, is an innovation-led biopharmaceutical company. It focuses on enhancing affordable access to complex therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases. Biocon has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and key global markets.