On August 3, 2026, Biocon Limited announced the commercial launch of its biosimilar YESAFILI (aflibercept-jbvf) in the United States. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor that is used to treat various ophthalmic conditions. YESAFILI references Regeneron’s EYLEA (aflibercept) 2 mg product.
The FDA approved YESAFILI as an interchangeable biosimilar in May 2024. However, a permanent injunction issued by the U.S. District Court for the Northern District of West Virginia on June 11, 2024, originally blocked Biocon from launching YESAFILI until at least the anticipated June 14, 2027 expiration of U.S. Patent No. 11,084,865. The parties entered into a settlement agreement in April 2025, and the district court then vacated the permanent injunction on April 22, 2025. As part of the settlement agreement, Biocon was permitted to launch YESAFILI in the United States in the second half of 2026 or earlier.
Separately, Biocon and Regeneron entered into an agreement on December 13, 2025, to dismiss all pending claims in the parties’ disputes over YESAFILI in Europe and the rest of the world (excluding Canada, which had been addressed in an earlier agreement). The December 2025 agreement allowed for Biocon to launch YESAFILI in the United Kingdom in January 2026 and the rest of the settled countries in March 2026 or earlier in certain circumstances.
With this launch, YESAFILI becomes the second aflibercept biosimilar commercially available in the United States. Amgen’s PAVBLU (aflibercept-ayyh) launched in October 2024 after Regeneron failed to secure a preliminary injunction against the product; litigation is still ongoing between Regeneron and Amgen concerning PAVBLU. Stay tuned for more updates!