U.S. High Court Won't Hear Novartis Appeal on Enbrel Biosimilar
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
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
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 email@example.com
(END) Dow Jones Newswires
May 17, 2021 11:38 ET (15:38 GMT)
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