Biocon Biologics announced a major milestone in its US expansion plans, inking a settlement and licensing agreement with Regeneron, allowing it to commercialise its biosimilar eye drug, Yesafili, in the country.
Yesafili, a vascular endothelial growth factor (VEGF) inhibitor, is a biosimilar to the widely used ophthalmology drug Eylea (aflibercept)), and is used to treat various vision-related conditions.
The agreement settled ongoing legal proceedings in the US court of appeals for the Federal Circuit and the US district court for the northern district of West Virginia. While the financial and legal terms of the deal remain confidential, the company confirmed that the settlement allowed it to launch Yesafili in the US market in the second half of 2026, or earlier under certain conditions.
“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 US,” said Shreehas Tambe, CEO & managing director of Biocon Biologics.
He further added, being the first-to-file interchangeable biosimilar to Eylea, Yesafili affirmed the pharma giant’s scientific strength and marked its strategic entry into ophthalmology andin the US.
Yesafili received approval from the US food and drug administration (USFDA) in May 2024 as an interchangeable biosimilar, making it a strong contender in the growing biosimilar market.
Biocon Biologics has also reached a separate settlement in Canada with Bayer Inc and Regeneron Pharmaceuticals, Inc, paving the way for the Canadian launch of Yesafili by no later than July 1, 2025.
After the agreement was announced, Biocon shares rose 3.29% to Rs 326.95 on the BSE.