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On March 16, 2026, Celltrion, Inc. announced the U.S. commercial launch of AVTOZMA® (tocilizumab-anoh) SC, a subcutaneous formulation of its tocilizumab biosimilar referencing Roche's ACTEMRA. Celltrion had previously launched its intravenous AVTOZMA® in October 2025. With this new launch, AVTOZMA® becomes one of the first tocilizumab biosimilars to have both an intravenous (IV) and subcutaneous (SC) formulation approved by the FDA and commercially available in the United States.
In January 2025, the FDA approved AVTOZMA® for subcutaneous and intravenous use based on data from a global Phase III clinical trial evaluating the biosimilar's efficacy, pharmacokinetics, safety, and immunogenicity against reference tocilizumab. In July 2025, the FDA further approved the IV formulation for an additional indication covering cytokine release syndrome (CRS) in adult and pediatric patients aged two years and older.
The SC formulation of AVTOZMA® is indicated for the treatment of rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (SJIA). It is available as a 162 mg/0.9 mL solution for injection in a single-dose prefilled syringe or autoinjector, enabling patients to self-administer the treatment at home.
The post Celltrion Announces AVTOZMA (tocilizumab-anoh) Now Available in U.S. appeared first on Big Molecule Watch.
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