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Roche’s Subcutaneous Ocrelizumab Registered in Australia

Mar 27, 2025

On 27 March 2025, Roche’s subcutaneous Ocrevus® (ocrelizumab) was listed on the Australian Register of Therapeutic Goods (ARTG). This adds to the intravenous formulation of Ocrevus® listed on the ARTG in July 2017.  Both formulations are indicated for the treatment of patients with primary progressive and relapsing forms of multiple sclerosis.

In January 2025, at the JP Morgan Annual Healthcare conference, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) undergoing Phase 3 trials.  Celltrion also has an ocrelizumab biosimilar in development, announcing in August 2023 that the European Medicines Agency (EMA) had partially approved its Phase 3 IND for CT-P53 (ocrelizumab).