Biocon Expands into US Ophthalmology Market with Yesafili Approval

On May 21, 2024, Biocon Ltd informed the stock exchanges that the United States Food and Drug Administration (US FDA) had approved its first-to-file application for Yesafili (aflibercept – jbvf), an interchangeable biosimilar aflibercept.

YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat various ophthalmologic conditions, is a biosimilar to its reference product, EYLEA® (aflibercept).

YESAFILI is prescribed for treating neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema from retinal vein occlusion (branch RVO or central RVO), visual impairment due to myopic choroidal neovascularisation and visual impairment from diabetic macular oedema (DME). It is mostly equivalent to the reference product Eylea® (aflibercept). Data indicates that YESAFILI matches Eylea® in safety, quality and efficacy.

The approval of YESAFILI makes Biocon Biologics, a subsidiary of Biocon Ltd, expand into the ophthalmology therapeutic area in the United States. Following a continuous track record of approval in Europe in September 2023 and the United Kingdom in November 2023, where it was the first biosimilar aflibercept to be approved, the company has secured a launch date in Canada before July 1, 2025, as per the terms of a settlement agreement.

The company stated that 19.8 million Americans in the USA live with age-related macular degeneration (AMD). In 2023, the sales of aflibercept in the USA were approximately $5.89 billion.

Commenting on this approval, the CEO and Managing Director of Biocon Biologics Ltd, Shreehas Tambe, said, “The FDA approval of YESAFILI (aflibercept) as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics marking our entry into Ophthalmology, a new therapeutic area in the United States.”

He further added, “This approval builds on our successful track record of bringing the first interchangeable insulin, SEMGLEE®, the first biosimilar Trastuzumab, OGIVRI®, and the first biosimilar Pegfilgrastim, FULPHILA®, to patients in the United States.”

The Chief Commercial Officer of Advanced Markets at Biocon Biologics Ltd, Matt Erick, said, “Biosimilars are crucial for making healthcare more affordable and accessible. YESAFILI will offer ophthalmologists an important new option for patients impacted by macular degeneration and diabetic retinopathy from a company with a long history of delivering high-quality, science-driven medicines, solely focused on the development and commercialisation of biosimilars.”

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