Avtozma FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 18, 2025.
FDA Approved: Yes (First approved January 24, 2025)
Brand name: Avtozma
Generic name: tocilizumab-anoh
Dosage form: Injection
Company: Celltrion USA
Treatment for: Rheumatoid Arthritis, Giant Cell Arteritis, Polyarticular Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis, Cytokine Release Syndrome, COVID-19
Avtozma (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist biosimilar to Actemra used for treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, cytokine release syndrome, and COVID-19.
- Avtozma is indicated for the treatment of:
- adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
- adult patients with giant cell arteritis.
- patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
- patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
- adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome.
- 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). - FDA approval was based on clinical data that demonstrated that Avtozma is highly similar to Actemra and that there are no clinically meaningful differences between the biosimilar product and the reference product.
- Avtozma is approved in the following presentations:
Product Presentation Strength Biosimilar / Interchangeable Single-Dose Vial 80 mg / 4 mL (20 mg / mL) Interchangeable Single-Dose Vial 200 mg / 10 mL (20 mg / mL) Interchangeable Single-Dose Vial 400 mg / 20 mL (20 mg / mL) Interchangeable Pre-Filled Syringe 162 mg / 0.9 mL Interchangeable Autoinjector 162 mg / 0.9 mL Biosimilar - Avtozma is not approved for all the same indications as Actemra. Actemra is approved for the same indications as Avtozma, and also for the treatment of systemic sclerosis-associated interstitial lung disease.
- Avtozma is administered by intravenous infusion or subcutaneous injection.
- The Avtozma product label carries a Boxed Warning for the increased risk of serious infections. Warnings and precautions associated with Avtozma include serious infections, gastrointestinal (GI) perforation, hepatotoxicity, laboratory abnormalities, and hypersensitivity reactions. Live vaccines should be avoided.
- Common adverse reactions include upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased alanine transaminase (ALT), and injection site reactions.
- Avtozma is the third Actemra biosimilar approved in the United States after the approvals of Tyenne (tocilizumab-aazg) in 2024 and Tofidence (tocilizumab-bavi) in 2023.
Development timeline for Avtozma
| Date | Article |
|---|---|
| Aug 6, 2025 | Approval FDA Approves Expanded Indication for Avtozma (tocilizumab-anoh) Intravenous (IV) Formulation in Cytokine Release Syndrome (CRS) |
| Jan 30, 2025 | Approval FDA Approves Avtozma (tocilizumab-anoh), a Biosimilar to Actemra |
Further information
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