Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili

Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili

By: IPP Bureau

Last updated : May 21, 2024 10:43 am



The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States


The U.S. Food and Drug Administration (US FDA) has approved Biocon Biologics first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept. YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product EYLEA (aflibercept).

YESAFILI is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is highly similar to the reference product Eylea (aflibercept). Data shows that YESAFILI has comparable quality, safety, and efficacy to Eylea.

The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States following a steady track record of approval in Europe (September 2023) and the United Kingdom (November 2023) where it was the first biosimilar aflibercept to be approved. The Company has secured a launch date in Canada of no later than July 1, 2025, under the terms of a settlement agreement.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., 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. YESAFILI is approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy." 

Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics Ltd, 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."

There are 19.8 million Americans living with age-related macular degeneration (AMD) in the United States.1 In the U.S., sales of aflibercept were approximately US$ 5.89 billion in 2023.

Biocon Biologics USFDA Shreehas Tambe Matt Erick

First Published : May 21, 2024 12:00 am