Biosimilar Humira Blocked Until 2023, But Time Could Clear Commercial Path

Amgen settled patent infringement litigation with AbbVie, allowing its Humira biosimilar Amjevita to launch in Europe in October 2018, but blocking entry in the US until 2023. The deal could set a bar for other Humira biosimilar developers.

AbbVie Inc. scored an important win in its all-important effort to extend the exclusivity of its top-selling blockbuster Humira (adalimumab) for several more years through a patent infringement settlement with its primary challenger, Amgen Inc. The agreement announced Sept. 28 will block US entry of Amgen's adalimumab biosimilar, Amjevita, until Jan. 31, 2023, although it will allow for the biosimilar to launch in Europe on Oct. 16, 2018.

The companies agreed to dismiss ongoing patent litigation, with AbbVie granting Amgen patent licenses for the use and sale of Amjevita worldwide on a country-by-country basis

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