The US Food and Drug Administration (USFDA) has approved the company’s first-to-file application for Yesafili, a vascular endothelial growth factor inhibitor for treating various ophthalmic conditions, according to a company statement.

Biocon Biologics Receives USFDA Approval for Biosimilar Product to Treat Ophthalmic Conditions

On Tuesday, Biocon Biologics announced it has received approval from the US Food and Drug Administration (USFDA) for its biosimilar product, Yesafili, designed to treat various ophthalmic conditions.

The USFDA approved the company’s first-to-file application for Yesafili, a vascular endothelial growth factor inhibitor. Yesafili is intended to treat neovascular age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion, visual impairment due to diabetic macular edema, and visual impairment due to myopic choroidal neovascularization. It is similar to the reference product Eylea (aflibercept).

Biocon Biologics, a part of Biocon Ltd, highlighted that this approval builds on its successful track record of introducing the first interchangeable insulin, Semglee; the first biosimilar Trastuzumab, Ogivri; and the first biosimilar Pegfilgrastim, Fulphila, to patients in the US.

Biocon Biologics CEO & Managing Director Shreehas Tambe stated, “This approval builds on our successful track record of bringing innovative biosimilars to the market.”

According to the company, there are 19.8 million Americans living with age-related macular degeneration. In the US, sales of aflibercept reached approximately USD 5.89 billion in 2023.

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