Fresenius Kabi becomes latest to settle patent litigation with AbbVie over Humira biosimilar

AbbVie and Fresenius Kabi reached an agreement regarding global patent infringement lawsuits related to the former's Humira (adalimumab), the drugmakers announced Thursday. Under the agreed terms, Fresenius will be permitted to launch a biosimilar version of the drug in the US in 2023 and in the EU once it gains clearance from the European Medicines Agency.

As part of the settlement, AbbVie will grant Fresenius a non-exclusive license to intellectual property related to Humira, with the latter paying royalties. Fresenius will acknowledge the validity of the licensed patents, while all pending litigation between the drugmakers will be dismissed. The precise financial terms of the agreement were not released.

While patent protection on Humira recently expired in Europe, allowing biosimilars to launch, in the US, AbbVie said that Fresenius' license period will begin on September 30, 2023 and "will not be accelerated by the entry of companies who have already taken a license." AbbVie has previously reached similar agreements to settle US patent litigation with drugmakers including Amgen, Biogen and Samsung Bioepis, Mylan and Novartis' Sandoz unit.  

Michael Schönhofen, president of Fresenius' pharmaceutical division, remarked "this agreement is a major step on our way to successfully developing and commercialising our biosimilar portfolio." Fresenius indicated that it expects to launch its Humira biosimilar, dubbed MSB11022, in Europe in the first half of next year after submitting a marketing application in December last year.  

Earlier this week, Amgen and Sandoz became the first drugmakers to launch biosimilar versions of Humira in Europe, with Biogen and Samsung Bioepis' product becoming available shortly afterwards.

For related analysis, see ViewPoints: Humira on the cusp as biosimilar D-Day nears in Europe.

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