Biocon Biologics secures market entry date for Eylea biosimilar
Biocon Biologics has reached 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 inhibitor, is used to treat several different types of ophthalmology conditions and is a biosimilar of Regeneron's 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 of patent US11084865 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.
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Shreehas Tambe, CEO and managing director of Biocon Biologics, 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.”
The Food and Drug Administration approved Yesafili 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.
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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).