Biocon Biologics Secures Market Entry Date for Yesafili, Interchangeable Biosimilar to Eylea in the US

Biocon Biologics announced a settlement and license agreement with Regeneron that clears the way 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 Eylea (aflibercept).

Biocon Biologics and Regeneron executed the settlement agreement to dismiss the pending appeal at the United States Court of Appeals for the Federal Circuit (USCAFC) of patent US11084865 (‘865 patent) and the pending litigation at the U.S. District Court for the Northern District of West Virginia, Clarksburg Division.

This agreement enables the company to launch in the United States in the second half of calendar year 2026 or earlier in certain circumstances. The terms of the settlement are confidential.

“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," Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said in a company news release. "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 US and advancing our mission to increase access to life-changing treatments.”

Previously, the FDA approved Yesafili (aflibercept-jbvf), an interchangeable* biosimilar aflibercept in May 2024. Additionally, Biocon Biologics secured a settlement agreement in Canada with Bayer and Regeneron Pharmaceuticals for the launch of Yesafili no later than July 1, 2025.

Yesafili is intended for the treatment of wet age-related macular degeneration (AMD), visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is highly similar to the reference product Eylea (aflibercept).

An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products.