Biogen, Samsung Bioepis settle litigation with AbbVie over Humira biosimilar, allowing EU, US launch

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Biogen and partner Samsung Bioepis announced Thursday a licensing agreement allowing the companies to launch Imraldi, a biosimilar version of AbbVie's Humira (adalimumab), in Europe on October 16. Under the terms of the deal, which settles all pending patent litigation between the parties, Samsung Bioepis is also permitted to launch its product, if approved, in the US from June 30, 2023 onwards.

AbbVie general counsel Laura Schumacher remarked "the Samsung Bioepis settlement reflects the strength and breadth of AbbVie's intellectual property," adding "we continue to believe biosimilars will play an important role in our healthcare system, but we also believe it is important to protect our investment in innovation."

Imraldi was cleared by the European Commission last August, while the product, also known as SB5, is not yet authorised in the US. Under the agreed terms, AbbVie will be eligible for royalty payments on sales of the therapy, although further details were not provided.

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"The earliest impact of this agreement will likely be seen in Europe, where SB5 has already been approved and is expected to become our third TNF inhibitor available in the region," remarked Jaywoo Kim, head of Samsung Bioepis's commercial division. Biogen and Samsung Bioepis previously received European approval of Benepali, a biosimilar referencing Amgen's Enbrel (etanercept), and Flixabi, a biosimilar version of Johnson & Johnson and Merck & Co.'s Remicade (infliximab).  

Last year, Amgen reached a similar global settlement with AbbVie under which it expects to launch Amjevita, its biosimilar version of Humira, in Europe on October 16 this year and in the US on January 31, 2023. AbbVie later indicated that sales of Humira are expected to be nearly $21 billion in 2020, up from a prior prediction of more than $18 billion.

For additional analysis, see ViewPoints: AbbVie concedes biosimilar defeat in Europe by shoring up its US Humira empire, and ViewPoints: European payers gear up for 2018's biosimilar windfall.