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.