Amgen gets early win in Regeneron lawsuit over Eylea biosimilar
By Blake Brittain
Sept 23 (Reuters) -Regeneron REGN.O cannot immediately block U.S. sales of rival Amgen's AMGN.O proposed copy of its blockbuster eye-care drug Eylea, a federal judge in West Virginia said on Monday.
Regeneron has accused Amgen's biosimilar version of Eylea of infringing dozens of its patents. U.S. District Judge Thomas Kleeh on Monday rejected Regeneron's request for a preliminary injunction against Amgen as it pursues the patent lawsuit.
Eylea earned Regeneron $5.89 billion in U.S. sales in 2023. Regeneron stock was down 4.6% when markets closed on Monday afternoon.
Spokespeople for Regeneron did not immediately respond to a request for comment on the decision. The company said in a court filing on Monday that it had appealed.
An Amgen spokesperson said in a statement that the company was pleased with the decision and will announce its timeline for launching its biosimilar Pavblu "in due course."
The judge's decision explaining his denial was issued under seal.
Biosimilars are versions of biologic drugs that are comparable to generics of traditional pharmaceuticals. Unlike traditional drugs, complex biologic drugs are made from living cells and cannot be copied exactly.
The U.S. Food and Drug Administration approved Tarrytown, N.Y.-based Amgen's biosimilar of Eylea last month.
Thousand Oaks, California-based Regeneron's Eylea can be used to treat eye diseases like macular degeneration, macular edema and retinopathy. The FDA first approved the drug in 2011.
Regeneron has sued several other competitors over their proposed Eylea biosimilars, and brought its lawsuit against Amgen in California federal court in January. The case was moved to West Virginia in April.
The case is Regeneron Pharmaceuticals Inc v. Amgen Inc, U.S. District Court for the Northern District of West Virginia, No. 1:24-cv-00039.
For Regeneron: David Berl, Ellen Oberwetter, Thomas Fletcher, Andrew Trask, Teagan Gregory, Shaun Mahaffy and Kathryn Kayali of Williams & Connolly; Elizabeth Stotland Weiswasser, Anish Desai, Natalie Kennedy and Christopher Pepe of Weil Gotshal & Manges; Andrew Goldsmith, Evan Leo and Jacob Hartman of Kellogg, Hansen, Todd, Figel & Frederick
For Amgen: Jeffrey Lamken of MoloLamken; John Labbe and Kevin Flowers of Marshall, Gerstein & Borun; Anthony Figg, Joseph Hynds, Jennifer Nock and Brett Postal of Rothwell, Figg, Ernst & Manbeck
Read more:
Regeneron asks US court to block Amgen's Eylea biosimilar
Reporting by Blake Brittain in Washington
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