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Further woes for AbbVie Humira® empire as EC grants MA for Sandoz’ adalimumab biosimilar Hyrimoz®

Apr 3, 2023

Sandoz announced that the EC granted marketing authorisation in the EU for its citrate-free high concentration (100mg/ml) formulation of its Hymiroz® (adalimumab), biosimilar to AbbVie’s Humira®, for all indicates covered by Humira®.

On 21 March 2023, the Sandoz citrate-free high concentration formulation of adalimumab Hymiroz® was approved by the FDA.  Sandoz intends to launch in the US on 1 July 2023 pursuant to its 2018 settlement with AbbVie.