United States: New York-based biotech company Regeneron has sued rival Amgen in federal court in Los Angeles, alleging that Amgen's proposed biosimilar of Regeneron's blockbuster eye drug Eylea violates its patent rights.
Regeneron said in its lawsuit filed on Wednesday that Amgen infringed dozens of its patents. It asked the court to block Amgen's version of Eylea, which earned Regeneron $6.26 billion in U.S. sales in 2022.
Amgen declined to comment on the lawsuit. Representatives for Regeneron did not immediately respond to requests for comment.
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.
Regeneron's Eylea can be used to treat eye diseases like macular degeneration, macular edema and retinopathy. The U.S. Food and Drug Administration first approved the drug in 2011.
Thousand Oaks, California-based Amgen's proposed biosimilar would infringe 32 patents covering the manufacture and use of Eylea, Regeneron's lawsuit said.
Regeneron has filed similar lawsuits against other biotech companies seeking to make Eylea biosimilars. A federal judge in West Virginia determined in December that Viatris' proposed biosimilar violated Regeneron's patent rights.
The case is Regeneron Pharmaceuticals Inc v. Amgen Inc, U.S. District Court for the Central District of California, No. 2:24-cv-00264.
For Regeneron: David Berl, Ellen Oberwetter, Thomas Fletcher, Andrew Trask, Teagan Gregory, Shaun Mahaffy and Kathryn Kayali of Williams & Connolly; Elizabeth Weiswasser, Anish Desai, Natalie Kennedy and Christopher Pepe of Weil Gotshal & Manges; Andrew Goldsmith and Jacob Hartman of Kellogg Hansen Todd Figel & Frederick
For Amgen: attorney information not yet available.
Original news source: https://www.reuters.com/legal/litigation/regeneron-asks-us-court-block-amgens-eylea-biosimilar-2024-01-11/
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