NEW DELHI: Biocon Biologics has announced that the US Food and Drug Administration (US FDA) has approved the company’s application for YESAFILI, the company informed the exchange in a filing.
“Biocon Biologics’ Obtains US FDA Approval for Biosimilar Aflibercept for Yesafili. Enters US Ophthalmology Market”, the company said.
After the approval, the company entered the ophthalmology therapeutic area in the United States. Earlier, the company also received approvals in Europe in September and the United Kingdom in November last year, where it was the first biosimilar aflibercept to be approved.
“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… pic.twitter.com/t129IIs1Qz
— Biocon Biologics (@BioconBiologics) May 21, 2024
“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”, said Shreehas Tambe, CEO and MD, Biocon Biologics.
The company has also secured a launch date in Canada of no later than July 1, 2025, under the terms of a settlement agreement.
YESDAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat several different types of ophthalmology conditions. YESAFILI is intended for the treatment of neovascular 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).
“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” said Matt Erick, Chief Commercial Officer, Biocon Biologics.
There are 19.8 million Americans living with age-related macular degeneration (AMD) in the United States. The sales of aflibercept in U.S. were approximately $5.89 billion in 2023. (ANI)