Regeneron’s stock $REGN dipped about 4% on Tuesday following a loss in its legal battle with Amgen over competitors to its blockbuster eye treatment Eylea.
While Regeneron previously defended itself in court from imminent competition, the US District Court for the Northern District of West Virginia on Monday denied Regeneron’s motion for a temporary injunction that would have stopped Amgen from launching Pavblu, its Eylea biosimilar. The biosimilar won FDA approval in August.
Regeneron has already appealed the decision, and a representative for the company wrote in an email to Endpoints News that it is “disappointed in the court decision that was specific to Amgen only.”
A representative for Amgen told Endpoints that the company is “pleased with the court’s decision” to deny the injunction, adding that its biosimilar doesn’t infringe on Regeneron’s patents and that it will announce the drug’s “launch timing in due course.”
Regeneron filed suits against Celltrion, Formycon, and Samsung in November 2023 after they let Regeneron know that they would begin marketing and selling their biosimilars following FDA approval. Then in January of this year, Regeneron also filed suit in California against Amgen. Those cases were combined in a multidistrict litigation in West Virginia that also includes Mylan and Biocon Biologics.
A spokesperson for Regeneron pointed out that the judge’s decision with Amgen “has no effect on previous decisions against other biosimilars manufacturers” and doesn’t impact Eylea HD, a higher dose of the drug.
“We continue to believe that Amgen is infringing our patent rights, and this decision denying our request for a preliminary injunction is not the final word in this litigation,” the representative added.
The FDA approved the first two biosimilars earlier this year — Biocon Biologics’ Yesafili and Samsung Bioepis and Biogen’s Opuviz — though because of remaining patents on Eylea, analysts don’t expect biosimilars to launch until 2027. Biocon said in a statement that it will launch its copy in Canada no later than July 1, 2025.
Regeneron also sued Sandoz in August in a New Jersey federal court over its Eylea copy Enzeevu. According to that complaint, Regeneron has 46 patents for Eylea, all of which Sandoz has violated.