Biocon Biologics Ltd announced a settlement and license agreement with Regeneron that clears the way for the company to commercialize Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept, in the United States. Yesafili, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions and is a biosimilar of its reference product aflibercept (Eylea; Regeneron). 

According to a press release, as originally reported by Retinal Physician, Biocon Biologics and Regeneron executed the settlement agreement to dismiss the pending appeal at the US Court of Appeals for the Federal Circuit of patent US11084865 and the pending litigation at the US District Court for the Northern District of West Virginia, Clarksburg Division. This agreement enables Biocon to launch Yesafili in the United States in the second half of 2026, or earlier in certain circumstances. The terms of the settlement are confidential, Biocon Biologics Ltd said in the press release. 

Additionally, Biocon Biologics secured a settlement agreement in Canada with Bayer and Regeneron for the launch of Yesafili no later than July 1, 2025, the company reported.

The US Food and Drug Administration (FDA) approved Yesafili in May 2024. The FDA’s designation of “interchangeable biosimilar” means that Yesafili may be substituted for the reference product without consulting the prescriber, similar to how generic drugs are substituted for brand name drugs.