Biocon Biologics secures USFDA approval for biosimilar product to treat ophthalmology conditions

The US Food and Drug Administration (USFDA) has approved Biocon's first-to-file application for Yesafili, a vascular endothelial growth factor inhibitor used to treat several different types of ophthalmology conditions.

New Delhi: Biocon Biologics on Tuesday said it has received approval from the US health regulator for its biosimilar product to treat different types of ophthalmology conditions.

The US Food and Drug Administration (USFDA) has approved the company's first-to-file application for Yesafili, a vascular endothelial growth factor inhibitor used to treat several different types of ophthalmology conditions, the company said in a statement.

Biocon Biologics is a part of Biocon Ltd.

Yesafili is intended for the treatment of neovascular age-related macular degeneration, 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.

It is similar to the reference product Eylea (aflibercept).

"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," Biocon Biologics CEO & Managing Director Shreehas Tambe said.

As per the company, there are 19.8 million Americans living with age-related macular degeneration in the US. In the US, sales of aflibercept stood at around $5.89 billion in 2023.