Biocon Biologics obtains USFDA approval for biosimilar Aflibercept

Biocon Biologics, announced that the U.S. Food and Drug Administration (US FDA) has approved the company’s 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 similar to the reference product Eylea (aflibercept). 

Shreehas Tambe, CEO & Managing Director, Biocon Biologics 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 said, “Biosimilars are crucial for making healthcare more affordable and accessible.”

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 $5.89 billion in 2023.(2)

1 Rein DB, Wittenborn JS, Burke-Conte Z, Gulia R, Robalik T, Ehrlich JR, Lundeen EA, Flaxman AD. Prevalence of Age-Related Macular Degeneration in the United States in 2019. JAMA Ophthalmology. Published Online: November 3, 2022 at: https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2797921. Accessed April 29, 2024.

2 Regeneron Fourth Quarter and Full Year 2023 Financial and Operating Results. February 2, 2024.

* An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of YESAFILI has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.