Biocon Subsidiary Secures Permission to Launch Eye Medicine Yesafili in US
A subsidiary of India-based Biocon, Biocon Biologics Limited (BBL), announced that it had struck a "settlement agreement" that permits it to introduce Yesafili, a medication used to treat specific adult eye disorders, in the US.
Under the terms of the deal with Regeneron, BBL may begin the medication's release in the second half of 2026 or, in some cases, earlier.
“This settlement clears the path for Biocon Biologics to be among the first to bring a reliable, high-quality aflibercept biosimilar to patients and health care providers in the United States,” said Shreehas Tambe, chief executive officer and managing director, BBL.
Eylea is a medication used to treat eye disorders by suppressing a protein called VEGF that results in aberrant blood vessel growth.
Yesafili is an interchangeable biosimilar of Eylea. It is recommended for the treatment of diabetic macular oedema, myopic choroidal neovascularization, neovascular (wet) age-related macular degeneration, and visual impairment brought on by macular oedema owing to retinal vein occlusion (branch or central RVO).
“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,” he said.
To dismiss a patent appeal before the US Court of Appeals for the Federal Circuit and the associated litigation in the US District Court for the Northern District of West Virginia, Clarksburg Division, BBL and Regeneron signed a settlement agreement.
Yesafili was authorized by the US Food and Drug Administration in May 2024. Separately, BBL and Bayer and Regeneron Pharmaceuticals came to a settlement agreement in Canada that allowed Yesafili to be launched by July 1, 2025.
In Canada, Biocon Biologics secured the rights to introduce Yesafili in that market by July 1, 2025, by reaching a similar arrangement with Regeneron and Bayer Inc.
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The company's future US launch and foray into the ophthalmology sector are in line with its overarching plan to increase the number of biosimilars it offers in regulated markets. This development indicates to business stakeholders that the US ophthalmology biologics market is becoming more competitive, which could have an impact on formulary dynamics and pricing once Yesafili is made available.