On December 13, 2025, Biocon Biologics Ltd. (“Biocon”) and Regeneron Pharmaceuticals, Inc. (“Regeneron”) entered into a license and settlement agreement to dismiss all pending claims in the parties’ disputes over Biocon’s aflibercept biosimilar, YESAFILI® (aflibercept-jbvf) in Europe and the rest of the world, following an earlier settlement covering the United States and Canada. Under the terms of the agreement, Biocon can 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.
As we previously reported, on April 22, 2025, Biocon and Regeneron had entered into a settlement agreement to resolve their BPCIA litigation in the United States over YESAFILI®. Under the terms of the agreement, Biocon can launch YESAFILI® in the United States in the second half of 2026. Biocon and Regeneron had also reached an agreement in March 2024 to allow Biocon to launch YESAFILI® in Canada no later than July 1, 2025, paving the way for Biocon’s launch in Canada this year.
Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (“VEGF-A”) and placental growth factor (“PlGF”), inhibiting abnormal vessel growth. In patients with neovascular age-related macular degeneration (“nAMD”), aflibercept is injected into the eye to improve visual acuity and inhibit disease progression.