Biopharmaceutical company Biocon Limited (BSE:532523) (NSE:BIOCON) announced on Monday the US commercial launch of Yesafili (aflibercept-jbvf), an FDA-approved interchangeable biosimilar to Eylea 2 mg.

The VEGF inhibitor is indicated for multiple ophthalmology conditions, including wet age-related macular degeneration, retinal vein occlusion-related macular oedema, diabetic macular oedema and diabetic retinopathy.

Clinical data from the Phase 3 INSIGHT Study demonstrated no clinically meaningful differences between Yesafili and Eylea 2 mg in pharmacokinetics, safety, efficacy and immunogenicity.

The US Food and Drug Administration (FDA) approved Yesafili and granted interchangeable designation in May 2024, allowing pharmacy-level substitution in accordance with state laws.

Biocon said the launch expands access to biosimilar aflibercept 2 mg treatments for patients with serious eye conditions.

The company highlighted the potential market opportunity, with an estimated 19.8 million Americans living with age-related macular degeneration and US aflibercept sales reaching approximately USD5.89bn in 2023.