Biocon Biologics Secures Global License for Biosimilar Aflibercept
Biocon Biologics has signed a settlement and license agreement with Regeneron and Bayer to commercialize its biosimilar Aflibercept (Yesafili®) worldwide. The agreement allows for launches in the UK in January 2026 and other settled countries in March 2026. This expands Biocon Biologics' presence in ophthalmology.
The agreement resolves litigation and enables global commercialization of a key biosimilar, which is expected to have a significant positive impact on Biocon Biologics' future revenue and market position in the ophthalmology segment.
The agreement allows Biocon Biologics to commercialize its biosimilar Aflibercept globally, expanding its market reach and patient access, which is a positive development for the company.
Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Limited, has announced a settlement and license agreement with Regeneron and Bayer for the worldwide commercialization of its biosimilar Aflibercept (40mg/ml). This agreement, which follows an earlier settlement for the United States and Canada, allows Biocon Biologics to launch its biosimilar, Yesafili®, globally.
Yesafili® is a vascular endothelial growth factor (VEGF) inhibitor used to treat various ophthalmology conditions. The agreement dismisses all pending litigation and enables the launch of Yesafili® in the United Kingdom in January 2026 and in other settled countries in March 2026, or earlier under specific circumstances. The other terms of the settlement remain confidential.
Shreehas Tambe, CEO & Managing Director of Biocon Biologics, stated that this settlement will enable the company to make its biosimilar Aflibercept available globally, expanding its presence in the ophthalmology therapeutic area and increasing patient access. Yesafili® has previously received approval from the European Commission (EC) and the Medicines & Healthcare products Regulatory Agency (MHRA).
Biocon Biologics had previously secured market entry for its biosimilar Aflibercept in the U.S. in April 2025, with a launch expected in the second half of calendar year 2026 or earlier. Yesafili® was launched in Canada earlier in the year, with market entry secured in March 2024.
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