Biocon Biologics Receives USFDA Approval For Biosimilar Yesafili

Biocon Biologics is a leading biosimilar provider with experience in other therapeutic areas. The company gets US FDA approval for Yesafili, a biosimilar for treating eye diseases like macular degeneration.

Biocon Biologics announced on Tuesday that it has received approval from the US Food and Drug Administration (USFDA) for its biosimilar product Yesafili, designed to treat various ophthalmology conditions. This approval marks a significant milestone for Biocon Biologics, a subsidiary of Biocon Ltd., as it expands its presence in the ophthalmology market.

Following the announcement, Biocon's shares were trading 1.63% higher at ₹309.50 apiece at 1.09 PM.

Yesafili, a vascular endothelial growth factor inhibitor, is intended for the treatment of several serious eye conditions, including neovascular age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion, visual impairment due to diabetic macular edema, and visual impairment due to myopic choroidal neovascularization. This biosimilar is similar to the reference product Eylea (aflibercept), which is widely used for these conditions.

Shreehas Tambe, CEO and Managing Director of Biocon Biologics  stated that, “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 US.”

Yesafili's approval is important given the high prevalence of age-related macular degeneration in the United States, which affects approximately 19.8 million Americans. In 2023, aflibercept sales in the US reached around USD 5.89 billion, highlighting the substantial market potential for Yesafili.

The entry of Biocon Biologics into the ophthalmic market in the US market is followed by first approval in Europe in September 2023 and the United Kingdom in November 2023, where Yesafili is the first biosimilar aflibercept to be approved.

Biocon Biologics is globally recognized as a contributor to healthcare, providing monoclonal antibodies, insulin and conjugated proteins. The company serves more than 5.5 million patients annually with its diverse portfolio of marketed and in-development biosimilars across various therapeutic areas.