Biocon Settles Litigation Over Yesafili

Biocon Ltd. on Tuesday said its subsidiary, Biocon Biologics, has reached a settlement agreement for its ongoing legal proceedings in the US and Canada related to its biosimilar drug Yesafili, clearing the way for a potential US launch in the second half of 2026 or earlier.

In an exchange filing, Biocon said it has reached an agreement to dismiss a pending appeal in the US Court of Appeals for the Federal Circuit, and has also resolved litigation before the US District Court for the Northern District of West Virginia, Clarksburg Division. The settlement terms remain confidential.

The company said the resolution enables Biocon Biologics to launch and commercialise Yesafili in the US. Yesafili is a biosimilar of Eylea, a vascular endothelial growth factor inhibitor used to manage eye disorders such as age-related macular degeneration and diabetic macular oedema. The US Food and Drug Administration had approved the drug in May 2024.

Separately, the company has also reached a settlement in Canada with Bayer Inc. and Regeneron Pharmaceuticals Inc., allowing the launch of Yesafili in the country no later than July 1.