Generics Bulletin

Digesting The Legal Landscape After Landmark US Eylea Biosimilar Nods

Regeneron Attempting To Win Injunction, Biocon Biosimilar Case Likely Expedited

22 May 2024

The US Food and Drug Administration has given the green light for biosimilar competition to the near $6bn eye-disease juggernaut Eylea, but a major legal overhang is currently throttling the potential for any near-term launches. Generics Bulletin explores the lay of the land, including the recent scheduling conference in the now-consolidated trial involving five aflibercept biosimilar sponsors.

Patent Box With Padlock — • Source: Chumakov Oleg

When it comes to treating wet age-related macular degeneration, Regeneron/Bayer’s Eylea (aflibercept) 2mg has long been the flagbearer. With annual sales of nearly $6bn in the US alone, biosimilar sponsors have planned for years to take a piece of the pie for themselves while delivering savings for the nation’s healthcare system.

All eyes were on the US Food and Drug Administration as the brand’s US regulatory exclusivity drew to a close on 17