Biocon Biologics secures market entry date for ophthalmology drug Yesafili in US

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.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said, “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. 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 U.S. and advancing our mission to increase access to life-changing treatments.”

Previously, the U.S. Food and Drug Administration (U.S. FDA) approved Yesafili (afliberceptjbvf), an interchangeable biosimilar aflibercept in May 2024.

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

YESAFILI is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema 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).

Data shows that YESAFILI has comparable quality, safety, and efficacy to Eylea.