Biocon Biologics (BBL), a subsidiary of Biocon, has entered into a settlement and licence agreement with Regeneron Pharmaceuticals, enabling the future commercialisation of its interchangeable aflibercept biosimilar, Yesafili (aflibercept-jbvf), in the United States.
The agreement settles ongoing litigation related to US Patent No. 11084865 (‘865 patent), which was pending before the United States Court of Appeals for the Federal Circuit and the U.S. District Court for the Northern District of West Virginia, Clarksburg Division. Under the agreement, the commercial launch of Yesafili in the United States is scheduled for the second half of calendar year 2026, or earlier under certain specified conditions. The terms of the settlement remain confidential.
Yesafili is a biosimilar to Eylea (aflibercept), a vascular endothelial growth factor (VEGF) inhibitor. It is intended for the treatment of various ophthalmology conditions, including neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV).
In May 2024, the US Food and Drug Administration (FDA) approved Yesafili as an interchangeable biosimilar to Eylea. This status allows for substitution at the pharmacy level, subject to state pharmacy laws, without requiring intervention from the prescribing healthcare provider. The product has demonstrated no clinically meaningful differences in quality, safety, or efficacy compared to its reference product.
Shreehas Tambe, CEO and Managing Director of Biocon Biologics , 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 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.”
Biocon Biologics had also reached a similar agreement in Canada with Bayer Inc. and Regeneron, securing the rights to launch Yesafili in that market no later than 1 July 2025.
The company’s entry into the ophthalmology segment and the upcoming US launch align with its broader strategy to expand its biosimilars portfolio in regulated markets. For business stakeholders, this development signals an increase in competition within the US ophthalmology biologics market, with potential implications for pricing and formulary dynamics once Yesafili becomes available.