Biocon Expands Global Biosimilar Portfolio with US Launch of Yesafili
Biocon Ltd. has strengthened its global biosimilars business with the commercial launch of Yesafili (aflibercept) in the United States, a biosimilar to EYLEA 2mg used to treat various ophthalmology conditions. The product had received approval and an interchangeable designation from the US Food and Drug Administration (USFDA) in May 2024, allowing pharmacists to substitute it for the reference product in line with state regulations.
The launch targets a significant market, with an estimated 19.8 million Americans living with age-related macular degeneration (AMD), including around 1.49 million affected by vision-threatening AMD. According to the company, aflibercept recorded approximately $5.89 billion in US sales during 2023, highlighting the size of the opportunity.
Beyond the US, Biocon continues to expand its global footprint, with its Canadian subsidiary recently receiving Health Canada approval for the Yesintek (ustekinumab) Autoinjector, following approvals for prefilled syringe, vial and intravenous infusion formats in October 2025.
The company also received approval from the European Medicines Agency (EMA) for a new fill-finish line for Semglee (insulin glargine) at its Malaysia facility, with supplies to Europe expected to begin in the second quarter of the current financial year. These developments reflect Biocon's continued focus on expanding access to biosimilars while strengthening its presence in key global pharmaceutical markets.