Biocon Biologics Gets US FDA Nod for Biosimilar Version of Eye Treatment Drug Eylea

Biocon Biologics said on Tuesday that the US Food and Drug Administration (US FDA) has approved the company’s first-to-file application for Yesafili, a biosimilar drug for treating eye ailments.

The company said the medicine is similar to the reference product Eylea (aflibercept) intended for the treatment of neovascular age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation. Studies demonstrate that Yesafili matches Eylea in quality, safety, and efficacy, it added.

"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. 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,” said Shreehas Tambe, chief executive officer and managing director, Biocon Biologics.

In the US, 19.8 million people live with AMD. In 2023, sales of aflibercept, a common treatment for AMD, were valued at around $5.89 billion, the statement added.