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Wednesday, July 1, 2020

Amgen: Appeals Court Affirms Enbrel Patent Validity in Sandoz Dispute

Amgen Inc. on Wednesday said a federal appeals court has upheld the validity of two patents related to Enbrel, turning away a challenge from a unit of Novartis AG that had hoped to launch a biosimilar to the blockbuster rheumatoid-arthritis drug.
Amgen said the U.S. Court of Appeals for the Federal Circuit affirmed a lower court ruling that upheld the validity of the patents and resulted in an injunction prohibiting Novartis’s Sandoz unit from launching an Enbrel biosimilar.
That injunction stands, Amgen said Wednesday.
Biosimilars are near-copies of biologic drugs, such as Enbrel, that are made from living cells and are analogous to generic copies of traditional pill-form medicines.
The Thousand Oaks, Calif., biotechnology company had sued Sandoz, claiming its biosimilar infringed on certain Enbrel patents, while Sandoz had argued that the patents were invalid.

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