Yesafili, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for treating a range of ophthalmology conditions. The biosimilar references Regeneron's blockbuster drug EYLEA, a widely prescribed treatment in the U.S. for retinal diseases.
As part of the settlement, Biocon Biologics and Regeneron agreed to dismiss ongoing litigation related to U.S. patent no. US11084865. This includes the pending appeal at the United States Court of Appeals for the Federal Circuit and the case in the U.S. District Court for the Northern District of West Virginia, Clarksburg Division.
While the financial and commercial terms of the settlement remain confidential, the agreement enables Biocon Biologics to potentially commercialize Yesafili in the U.S. starting in the second half of 2026—or earlier, depending on certain conditions.
The company has also secured a Canadian launch deal for Yesafili no later than 1 July 2025.
Shreehas Tambe, CEO & managing director, Biocon Biologics, said: "This settlement clears the path for Biocon Biologics to be among the first to bring a reliable, high-quality aflibercept biosimilar to patients and healthcare providers in the United States. As the first-to-file interchangeable biosimilar to Eylea, YESAFILI affirms our scientific strength and marks our strategic entry into Ophthalmology, expanding our footprint in the U.S. and advancing our mission to increase access to life-changing treatments."
Biocon is an innovation-led global biopharmaceuticals company. On a consolidated basis, its net profit slumped 96.20% to Rs 25.10 crore while net sales rose 6.32% to Rs 3773 crore in Q3 December 2024 over Q3 December 2023.