Biocon Biologics forays into US Ophthalmology market with USFDA nod for Yesafili

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. 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."

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. In the U.S., sales of aflibercept were approximately $5.89 billion in 2023. Biocon Biologics is a global company offering a large portfolio of monoclonal antibodies, insulins, and conjugated proteins. Serving over 5.5M patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including four in the United States and six in Canada, with a robust pipeline of 20 biosimilar assets spanning multiple therapy areas.

Read also: Biocon, Medix join hands for commercialization of weight management drug Liraglutide in Mexico