Biocon subsidiary secures permission to launch eye medicine Yesafili in US

Agreement enables company to make 'strategic entry' in ophthalmology sector in the US, it says

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Biocon Biologics Limited (BBL), a subsidiary of India-based Biocon, said on Tuesday it has reached a “settlement agreement” that allows it to launch Yesafili, a medicine used to treat certain eye conditions in adults, in the United States.

 

The agreement with Regeneron allows BBL to initiate the launch of the medicine in the second half of 2026 or earlier under certain circumstances. “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.

 

“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.

 

Yesafili is an interchangeable biosimilar of Eylea, a medicine used to treat eye conditions by blocking a protein called VEGF that causes abnormal blood vessel growth. It is indicated for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch or central RVO), diabetic macular oedema, and myopic choroidal neovascularisation.

 

BBL and Regeneron executed a settlement agreement to dismiss a patent appeal before the US Court of Appeals for the Federal Circuit and the related litigation at the US District Court for the Northern District of West Virginia, Clarksburg Division.

 

In May 2024, the US Food and Drug Administration approved Yesafili. Separately, BBL reached a settlement agreement in Canada with Bayer and Regeneron Pharmaceuticals, enabling the launch of Yesafili no later than July 1, 2025.