September 29, 2023
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Amgen settles with AbbVie over Humira biosimilar


Thousand Oaks biopharmaceutical giant Amgen announced Sept. 28 that it had reached a settlement with Chicago-based competitor AbbVie, which had sued to block Amgen’s Humira biosimilar Amjevita.

The rheumatoid arthritis and inflammation treatment received U.S. Food and Drug Administration approval in September of 2016, but sales were blocked when AbbVie filed a patent infringement claim against Amgen and alleged that it had violated the Biosimilar Price Competition and Innovation Act.

Under the terms of the settlement, the two companies have agreed to drop all pending litigation, and AbbVie will grant patent licenses for the copycat drug on a country-by-country basis. It is expected to be launched in Europe in October of 2016. U.S. sales won’t begin until Jan. 31, 2023, according to the news release.

The companies did not disclose financial terms of the deal. Humira brought in $16.1 billion for Abbvie in 2016, and treatments cost around $20,000 per year.

“Amgevita will be one of our first biosimilar launches, and this agreement will allow us to secure a strong foothold in the $4 billion European adalimumab market,” said Scott Foraker, vice president and general manager of biosimilars at Amgen. “Building on our strong inflammatory disease presence in the United States, we are excited to develop our inflammation capabilities in Europe, extending our reach and helping more patients gain access to this important class of therapies.”

The drug was the fourth biosimilar to get approval in the U.S. and the first for Amgen. It has since gotten approval for its Avastin biosimilar Mvasi in the treatment of cancer patients and has a total of 10 in its pipeline.

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