Biocon Biologics signs deal, gets market entry for Yesafili in US by 2026

Biocon Biologics on Tuesday said it has inked a settlement and licensing pact with Regeneron, paving the way to commercialise its biosimilar product Yesafili in the US.

Yesafili, a vascular endothelial growth factor (VEGF) inhibitor used to treat several types of ophthalmology conditions, is a biosimilar of its reference product Eylea (aflibercept).

Biocon Biologics and Regeneron executed the settlement agreement to dismiss the pending appeal at the US Court of Appeals for the Federal Circuit (USCAFC) and the pending litigation at the US District Court for the Northern District of West Virginia, Clarksburg Division, Biocon Biologics said in a statement.

The agreement enables the company, a unit of Biocon Ltd, to launch its product in the US in the second half of 2026 or earlier in certain circumstances, it added.

The terms of the settlement are confidential, it stated.

"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," Biocon Biologics CEO & Managing Director Shreehas Tambe said.

As the first-to-file interchangeable biosimilar to Eylea, Yesafili affirms company's scientific strength and marks strategic entry into ophthalmology, expanding footprint in the US, he added.

The US Food and Drug Administration (USFDA) had approved Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept, in May 2024.

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

The product is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation.

Biocon shares were trading 3.29 per cent up at Rs 326.95 apiece on BSE.