By Colin Kellaher


Novartis AG's Sandoz unit on Monday said the U.S. Supreme Court won't review a lower court ruling that will keep a Sandoz biosimilar to Amgen Inc.'s blockbuster rheumatoid-arthritis drug Enbrel off the U.S. market until 2029.

The U.S. Food and Drug Administration in August 2016 approved Sandoz's Erelzi biosimilar to Enbrel, but Amgen filed suit, claiming infringement on certain Enbrel patents.

Sandoz had argued that the patents were invalid, but the U.S. Court of Appeals for the Federal Circuit last year affirmed a lower court ruling that upheld the validity of the patents and resulted in an injunction prohibiting Sandoz from launching Erelzi in the U.S.

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.

Sandoz said the Supreme Court decision means Erelzi won't be available to U.S. patients until 2029, after Amgen's Enbrel patents have expired.

Amgen, a Thousand Oaks, Calif., biotechnology company, reported worldwide Enbrel sales of roughly $5 billion last year, including more than $4.8 billion in U.S. sales.


Write to Colin Kellaher at


(END) Dow Jones Newswires

May 17, 2021 11:38 ET (15:38 GMT)

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