By: IPP Bureau
Last updated : August 04, 2026 7:37 am
FDA-approved aflibercept biosimilar strengthens Biocon's ophthalmology portfolio and expands patient access to affordable vision care
Biocon Limited has announced the commercial launch of Yesafili (aflibercept-jbvf) in the United States, marking a significant expansion of its biosimilars portfolio in ophthalmology.
The product is an interchangeable biosimilar to EYLEA (aflibercept) 2 mg, a widely prescribed vascular endothelial growth factor (VEGF) inhibitor used to treat several retinal diseases.
Yesafili received approval from the U.S. Food and Drug Administration (FDA) in May 2024, along with an interchangeable designation, enabling pharmacists to substitute it for the reference product in accordance with applicable state pharmacy laws. The launch positions Biocon among the first companies to commercialize an interchangeable biosimilar version of aflibercept in the U.S. market.
Shreehas Tambe, CEO & Managing Director, Biocon Ltd., said, “The launch of Yesafili in the U.S. marks an important step in expanding the global availability of biosimilar Aflibercept 2 mg for patients with eye conditions. This milestone further strengthens our presence in ophthalmology and builds on our FDA approval as one of the first interchangeable biosimilars to Eylea 2 mg, advancing access to life-changing medicines for patients around the world.”
The launch addresses a substantial and growing clinical need in the United States, where an estimated 19.8 million Americans are living with age-related macular degeneration (AMD), one of the leading causes of irreversible vision loss among older adults.
The reference product, EYLEA, generated approximately US$5.89 billion in U.S. sales in 2023, highlighting the significant market opportunity for biosimilar alternatives.
Yesafili is indicated for the treatment of various ophthalmic conditions, including those associated with retinal vascular disorders, and is expected to improve patient access to high-quality biologic therapies while supporting healthcare cost savings through increased biosimilar adoption.
The launch further reinforces Biocon's strategy of expanding its global biosimilars franchise and strengthening its presence in key therapeutic segments by offering affordable, high-quality biologic medicines in regulated markets.