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AbbVie Humira® empire spirals as FDA approves Sandoz adalimumab biosimilar Hyrimoz®

Mar 21, 2023

Sandoz announced that it has received FDA approval for its Hyrimoz® (adalimumab), biosimilar to AbbVie’s Humira® in a citrate-free, high concentration formulation that it intends to launch in the US on 1 July 2023 pursuant to the licence granted in its settlement with AbbVie on 11 October 2018.  Hyrimoz® is approved for the same seven indications as the reference product, AbbVie’s Humira®.

This follows Amgen’s recent launch of Amjevita®, the first adalimumab biosimilar available in the US on 31 January 2023 pursuant to its AbbVie settlement dated 28 September 2017.  In total, AbbVie entered into 11 deals with biosimilar entrants enabling US market entry as follows: Amgen (31 January 2023), Alvotech (1 July 2023), Celltrion (July 2023), Mylan/Viatris (31 July 2023), Sandoz (30 September 2023), Momenta (20 November 2023), Pfizer (20 November 2023), Fresenius Kabi (July 2023), Samsung Bioepis/Merck (30 June 2023), Coherus (1 July 2023) and Boehringer Ingelheim (1 July 2023).