Biocon Biologics gets USFDA approval for Yesafili, enters US ophthalmology market

Biocon Biologics (BBL), a subsidiary of Biocon, on Tuesday said it has received the United States Food and Drug Administration (USFDA) approval for Yesafili (aflibercept-jbvf), an interchangeable biosimilar of Eylea (aflibercept), marking its entry into the US ophthalmology market.

Yesafili is a vascular endothelial growth factor (VEGF) inhibitor used for the treatment of several ophthalmology conditions, including neovascular age-related macular degeneration (wet AMD), macular oedema after retinal vein occlusion (RVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV).

Biocon said data showed that Yesafili has comparable quality, safety, and efficacy to its reference product, Eylea. An interchangeable product is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product.

Shreehas Tambe, CEO and Managing Director of Biocon Biologics said the approval builds on the firm’s 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.

Biocon Biologics has already secured regulatory approvals for Yesafili in Europe (September 2023) and the United Kingdom (November 2023). The company also plans to launch in Canada by July 1, 2025, under an agreement.

Matt Erick, chief commercial officer of advanced markets at Biocon Biologics 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 commercialization of biosimilars," he said.

The number of Americans living with age-related macular degeneration (AMD) has reached 1.98 crore, the firm pointed out. In 2023, the sales of aflibercept stood at about $5.89 billion in the US.

Shares of Biocon have gained over 20% since the beginning of the year. The stock has gained over 28% in the last one year.