Biocon Biologics Ltd.—an arm of Biocon Ltd.—received approval from the US Food and Drug Administration for a drug used to treat different types of eye disorders, marking its entry in the segment in the world's top pharmaceutical market.
Yesafili, a vascular endothelial growth factor inhibitor, used to treat visual impairments, is a biosimilar of its reference product Eylea.
The approval of Yesafili marks Biocon Biologics' expansion into the ophthalmology therapeutic area in the US, following a steady track record of approval in Europe and the UK last year. The company has secured a launch date in Canada of no later than July 1, 2025, under the terms of a settlement agreement, a statement said on Tuesday.
Yesafili will offer ophthalmologists an important new option for patients impacted by macular degeneration and diabetic retinopathy, Matt Erick, chief commercial officer of advanced markets at Biocon Biologics, said.
There are 19.8 million Americans living with age-related macular degeneration in the US, and sales of Aflibercept were approximately $5.89 billion in 2023, the company said.
Shares of Biocon closed 0.82% higher at Rs 307.2 apiece on Tuesday, as compared with a flat BSE Sensex.
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