Biocon Biologics Announces Major US Expansion with Yesafili

In a significant move for the US pharmaceutical market, Biocon Biologics has finalized a settlement and licensing agreement with Regeneron. This pivotal deal paves the way for the commercialization of Yesafili, its biosimilar eye drug, in the United States.

Yesafili: A New Hope for Vision-Related Conditions

Yesafili, a vascular endothelial growth factor (VEGF) inhibitor, stands as a biosimilar to the renowned ophthalmology drug Eylea (aflibercept). It is designed to treat a variety of vision-related conditions, offering a new option for patients and healthcare providers.

Legal and Market Implications

The agreement marks the resolution of ongoing legal proceedings in US courts, setting the stage for Yesafili's launch in the US market by the second half of 2026. Shreehas Tambe, CEO & managing director of Biocon Biologics, highlighted the significance of being among the first to introduce a high-quality aflibercept biosimilar in the US.

Regulatory Approval and Future Prospects

Following its approval by the USFDA in May 2024 as an interchangeable biosimilar, Yesafili is poised to make a substantial impact in the biosimilar market. Additionally, Biocon Biologics has secured a settlement in Canada, aiming for Yesafili's launch by July 1, 2025.