Biocon Biologics clears global path to commercialise biosimilar aflibercept after settlement with Regeneron, Bayer
Under the settlement terms, Biocon Biologics plans to launch Yesafili in the United Kingdom in January 2026, followed by launches in other settled countries from March 2026, or earlier under certain circumstances.
Bengaluru, December 17: Biocon Biologics has signed a settlement and licence agreement with Regeneron and Bayer, clearing the way for global commercialisation of its biosimilar aflibercept, Yesafili, across Europe and other international markets.
The agreement follows an earlier settlement covering the United States and Canada and brings all pending litigation related to the molecule to a close. With this, Biocon Biologics is now authorised to commercialise Yesafili worldwide.
Yesafili, a biosimilar of aflibercept (40 mg/ml), is a vascular endothelial growth factor inhibitor used in the treatment of multiple ophthalmic conditions, including wet age-related macular degeneration, diabetic macular oedema, retinal vein occlusion and myopic choroidal neovascularisation.
Under the settlement terms, Biocon Biologics plans to launch Yesafili in the United Kingdom in January 2026, followed by launches in other settled countries from March 2026, or earlier under certain circumstances. The commercial terms of the agreement remain confidential.
“This settlement paves the way for Biocon Biologics to make our biosimilar aflibercept available globally,” said Shreehas Tambe, chief executive officer and managing director of Biocon Biologics. He said the milestone strengthens the company’s presence in ophthalmology and supports broader efforts to improve patient access to affordable biologic therapies.
Yesafili has already received regulatory approvals from the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency. Biocon Biologics secured market entry for the biosimilar in the United States in April 2025, with launch planned for the second half of calendar year 2026 or earlier in certain circumstances. The product was launched in Canada earlier this year following market entry approval in March 2024.
Biocon Biologics, a subsidiary of Biocon Ltd, has commercialised 10 biosimilars globally and maintains a pipeline of more than 20 assets across diabetology, oncology, immunology, ophthalmology and bone health. The company currently serves over 6.3 million patients across more than 120 countries.
The company said the agreement reinforces its strategy of expanding access to high-quality, affordable biosimilars while strengthening its position in advanced and emerging markets.
