Amgen is moving forward with the launch of Pavblu, its biosimilar to Regeneron’s blockbuster Eylea, following an appeals court decision that ruled against competitor Regeneron.
“We look forward to bringing Pavblu to patients as quickly as possible to help expand access to affordable and effective treatment,” Amgen said in a statement to Endpoints News.
A Regeneron spokesperson said in a statement that the company is “disappointed in today’s court decision. Regeneron has invested many years of effort into its design and development of” Eylea.
The spokesperson also said Regeneron continues to believe that Amgen is infringing its patent rights, and Tuesday’s decision “denying our request for a temporary injunction is not the final word in this litigation.” The drugmaker plans to appeal the decision and present its case at trial.
Last month, a West Virginia district court denied Regeneron’s motion for a preliminary injunction, but an appeals court issued an order temporarily enjoining the launch of Pavblu, which was approved by the FDA in August. The appeals court has now lifted that temporary injunction.
The FDA earlier this year approved the first two Eylea biosimilars — Biocon Biologics’ Yesafili and Samsung Bioepis and Biogen’s Opuviz. Because of remaining patents for Eylea, analysts have said they don’t expect other biosimilars to launch until 2027. Regeneron also sued Sandoz in August in New Jersey federal court over its Eylea copy, called Enzeevu.