Biocon Biologics Paves Path for US Launch of Aflibercept Biosimilar 'Yesafili'

Biocon Biologics has established a settlement with Regeneron, allowing the commercialization of its biosimilar Yesafili in the U.S. The company plans to launch by mid-2026 or earlier. Yesafili, an aflibercept biosimilar, targets ophthalmology conditions and underscores Biocon's entry into the U.S. market and scientific capabilities.

Biocon Biologics announced a major breakthrough with the signing of a settlement and licensing agreement with Regeneron, effectively setting the stage for the U.S. commercialization of its biosimilar product, Yesafili. This strategic move positions the company to introduce Yesafili, a biosimilar of aflibercept, to American healthcare providers by the second half of 2026 or possibly earlier under specific conditions.

The agreement also resolves legal challenges, including a pending appeal at the US Court of Appeals for the Federal Circuit and litigation in the Northern District of West Virginia, signifying a crucial step forward for Biocon in solidifying its presence in the biosimilars sector. The settlement's terms remain confidential, underscoring the competitive nature of this pharmaceutical pathway.

Biocon Biologics CEO, Shreehas Tambe, emphasized the strategic significance of this development, highlighting the product's FDA approval as an interchangeable biosimilar in 2024 and its intended use for treating various ophthalmic conditions such as neovascular age-related macular degeneration. This agreement not only marks Biocon's scientific prowess but also signifies a wider expansion into the U.S. ophthalmology market.

(With inputs from agencies.)