Amgen settles litigation with AbbVie over Humira biosimilar; sees US launch in 2023

Amgen announced Thursday that it reached a global settlement with AbbVie under which it expects to launch Amjevita, its biosimilar version of AbbVie's Humira (adalimumab), in the US on January 31, 2023. Under the deal, which resolves all pending litigation regarding Amjevita, Amgen is also targeting a launch of the product in Europe, under the name Amgevita, on October 16 next year. Amgen will pay royalties as part of the agreement, although specific financial terms of the deal were not disclosed. 

Scott Foraker, general manager of biosimilars at Amgen, remarked "we look forward to leveraging our existing biologics capabilities to bring high-quality biosimilars to patients worldwide." He added that "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." 

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In May, the US Patent and Trademark Office's Patent Trial and Appeal Board ruled in favour of Coherus BioSciences concerning the drugmaker's challenge of a patent covering Humira. The board had previously denied institution of Coherus' petition challenging a separate patent protecting the therapy. 

The FDA approved Amjevita in September 2016, while European regulators cleared the biosimilar this past March. For futher analysis, see ViewPoints: AbbVie's biosimilar settlement with Amgen could be decisive.

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