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Celltrion, Inc. announced that Avtozma (tocilizumab-anoh) intravenous (IV) formulation is now available to patients in the United States.
Avtozma IV is approved for all same indications as the reference product Actemra (tocilizumab), including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA), systemic juvenile idiopathic arthritis (SJIA), coronavirus disease (Covid-19) and cytokine release syndrome (CRS). Avtozma IV will be available in all the same formulations currently provided by Actemra IV. The available presentations are 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) in single-dose vials.
"Immune-mediated conditions such as rheumatoid arthritis have profound impact on patients' daily lives," said Prof. Gerd-Rüdiger Burmester, MD, Professor of Medicine and Rheumatology, Senior Professor in the Department of Rheumatology and Clinical Immunology at Charité - Universitätsmedizin Berlin, Germany. "The availability of a tocilizumab biosimilar gives physicians additional options to manage the disease and maintain continuity of care, which is a welcome news for both patients and clinicians."
"The launch of Avtozma IV reinforces Celltrion's strong commitment to providing physicians and patients with access to high-quality treatment options for serious immune-mediated diseases and to supporting the sustainability of the US healthcare system," said Thomas Nusbickel, chief commercial officer of Celltrion USA. "It also strengthens our immunology portfolio, expanding beyond TNF-a and IL-12/23 inhibitors, now including an IL-6 inhibitor, broadening coverage across inflammatory pathways and enhancing our ability to address a broader range of patient needs."
At launch, Avtozma IV will be supported by a comprehensive patient support resources for healthcare providers and patients, and copay support for eligible commercial patients prescribed Avtozma IV.
Avtozma (tocilizumab-anoh), containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global phase III clinical trial designed to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of CT-P47 compared to reference tocilizumab, Avtozma received approval from the US Food and Drug Administration (FDA) and European Commission (EC) in January and February 2025, respectively. In July 2025, the FDA approved an additional indication for the intravenous (IV) formulation of Avtozma for the treatment of cytokine release syndrome (CRS) in adult and paediatric patients aged two years and older.
Avtozma (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:
- Rheumatoid arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
- Giant cell arteritis (GCA): Adult patients with GCA.
- Polyarticular juvenile idiopathic arthritis (pJIA): Patients 2+ years-old with active pJIA.
- Systemic juvenile idiopathic arthritis (sJIA): Patients 2+ years-old with active sJIA.
- Cytokine release syndrome (CRS): Adults and paediatric patients 2+ years-old with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome
- Covid-19: Hospitalized adult patients with Covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar.
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