Celltrion has introduced the subcutaneous (SC) formulation of AVTOZMA (tocilizumab-anoh) in the United States, expanding the availability of its tocilizumab biosimilar beyond the previously launched intravenous (IV) presentation. AVTOZMA is among the first tocilizumab biosimilars with both IV and SC formulations approved by the FDA and commercially available in the U.S. market.
The SC formulation of AVTOZMA is indicated for the treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis in appropriate patient populations. It is supplied as a 162 mg/0.9 mL solution in single-dose prefilled syringes and single-dose prefilled autoinjectors, allowing for administration outside of infusion centers, including at-home use.
AVTOZMA contains tocilizumab, a recombinant humanized monoclonal antibody that acts as an interleukin-6 receptor antagonist. The biosimilar received initial U.S. FDA and European Commission approvals in early 2025 based on a global Phase III study assessing efficacy, pharmacokinetics, safety, and immunogenicity compared with reference tocilizumab. The IV formulation subsequently gained an additional U.S. indication for cytokine release syndrome in adults and pediatric patients aged two years and older, as well as an indication for certain hospitalized adults with COVID-19.
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