Armed with a new victory over Viatris in a patent dispute, Regeneron can knock off one contender in the Eylea biosimilar race.
A West Virginia judge ruled that Viatris' proposed biosimilar violates a Regeneron patent that covers ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist suitable for intravitreal administration to the eye. That patent is expected to expire in June 2027.
Viatris, a generic and biosimilar specialist created by Pfizer through the combination of its Upjohn business with Mylan back in 2020, was the first to file for a coveted Eylea biosimilar in 2021. Regeneron struck back with its suit in 2022, arguing that the proposed copycat steps on 24 of its patents. The complaint was later trimmed to three, according to Bloomberg. Viatris has since offloaded its biosimilars unit to Biocon Biologics in a $3.33 billion cash-and-stock deal.
Amgen tried to get into the litigation earlier this year ahead of the June trial, urging the judge to unseal documents as the public has a right to the filings including “potentially dispositive allegations” that the patents are unenforceable. The FDA accepted Amgen’s own Eylea biosimilar application in November after a phase 3 trial found no clinically meaningful differences in efficacy and safety between the original and Amgen’s biosimilar option.
Nonetheless, Regeneron isn’t done defending its crown jewel. Shortly after the Viatris win, the drugmaker widened its lawsuit against Samsung Biologics and its Eylea biosimilar hopeful. The new 83-page complaint alleges 51 patent infringements, including the one Viatris stepped on, according to Bloomberg Law, and builds on a West Virginia suit (PDF) the company filed in November.
Eylea’s regulatory exclusivity ends on May 17, 2024, with its key patent expiring in June. Other contenders in the biosimilar race include Alvotech and Novartis’ Sandoz, the latter of which found positive equivalency data over the summer. Meanwhile, Regeneron recently gained approval for its longer-lasting version of Eylea, dubbed Eylea HD, to compete with Roche’s newcomer Vabysmo.
The superstar eye drug pulled $1.49 billion in 2023’s third quarter, including $43 million from Eylea HD, and has been a major blockbuster drug for Regeneron.