Avtozma FDA Approval History

Last updated by Judith Stewart, BPharm on April 30, 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, 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, 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.
  - 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 and cytokine release syndrome.
• 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

Further information

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