Regeneron loses bid to block Amgen's Eylea biosimilar launch in US
Adds comments from Regeneron and Amgen in paragraphs 3-4, additional context in paragraphs 5-8
By Blake Brittain
Oct 22 (Reuters) -Amgen AMGN.O will launch its biosimilar version of Regeneron's REGN.O blockbuster eye care drug Eylea following a U.S. appeals court ruling in its favor on Tuesday, an Amgen spokesperson said.
The U.S. Court of Appeals for the Federal Circuit rejected Regeneron's request to block the launch during its appeal of a related decision for Amgen in a patent case in West Virginia. Eylea can treat eye diseases like macular degeneration, macular edema and retinopathy.
"We continue to believe that Amgen is infringing our patent rights, and today's decision denying our request for a temporary injunction is not the final word in this litigation," Regeneron said in a statement.
An Amgen spokesperson said that the company will bring its biosimilar, Pavblu, to patients "as quickly as possible to help expand access to affordable and effective treatment."
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 FDA first approved Eylea in 2011. It earned Regeneron $5.89 billion in U.S. sales in 2023.
Tarrytown, N.Y.-based Regeneron sued Thousand Oaks, California-based Amgen for infringing dozens of its patents related to Eylea. A West Virginia federal judge last month rejected Regeneron's request to block Amgen's launch of Pavblu while Regeneron pursues its patent claims against the company in the ongoing case.
Regeneron appealed to the Federal Circuit and asked the court to issue its own block on the Pavblu launch through the appeal. The Federal Circuit rejected the request on Tuesday, allowing Amgen to go forward with the launch.
Reporting by Blake Brittain; Editing by David Bario, Leslie Adler and Lisa Shumaker
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