Biosimilars – Corporate Strategies – Reference Brand Developer Strategies

AbbVie has rigorously defended the IP surrounding its multibillion-dollar product Humira in the United States, resulting in a favorable outcome that is set to prevent biosimilar entry for several years following key patent loss. Despite the constraining composition patent held by AbbVie for Humira (U.S. 6090382) expiry in December 2016, the company has used the considerable outstanding U.S. patent estate held for Humira to restrict adalimumab biosimilar competition. Amgen filed its adalimumab biosimilar, Amjevita, with the FDA in November 2015, opening up use of the BPCIA to resolve patent disputes between the biosimilar sponsor and the reference-product sponsor. In January 2016, Amgen attempted, but ultimately failed, to have the two formulation patents (U.S. 8916157 and U.S. 8916158) invalidated by the U.S. Patent Office via an inter partes review.

In September 2016, Amjevita was the first adalimumab biosimilar to receive FDA approval, but its launch was delayed due to ongoing patent litigation with AbbVie, which initially filed complaints regarding 10 Humira patents in the first wave of litigation and identified a further 51 patents with which to potentially challenge Amgen in the second wave of litigation. In September 2017, AbbVie announced an end to all related pending legal action. The settlement resulted in AbbVie granting Amgen patent licenses to market Amjevita beginning in January 2023 in the United States and in October 2018 in Europe.

To date, the FDA has approved six adalimumab biosimilars: Amgen’s Amjevita, Boehringer Ingelheim’s Cyltezo, Merck & Co.’s Hadlima, Mylan’s Hulio, Pfizer’s Abrilada, and Sandoz’s Hyrimoz. AbbVie has agreed on the launch dates for these six agents. Four more biosimilars companies have either filed for regulatory approval of an adalimumab biosimilar or have one in late-phase development in the United States (see “U.S. Launch Dates” table). AbbVie’s settlement with these companies centers on a nonexclusive IP license to market the adalimumab biosimilars in exchange for royalty payments to AbbVie. The terms of the deals were not disclosed.

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