Tyenne FDA Approval History

Last updated by Judith Stewart, BPharm on March 17, 2025.

FDA Approved: Yes (First approved March 5, 2024)
Brand name: Tyenne
Generic name: tocilizumab-aazg
Dosage form: Injection
Company: Fresenius Kabi USA, LLC
Treatment for: Rheumatoid Arthritis, Giant Cell Arteritis, Polyarticular Juvenile Idiopathic Arthritis, Juvenile Idiopathic Arthritis, Cytokine Release Syndrome, COVID-19

Tyenne (tocilizumab-aazg) 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.

• Tyenne is indicated for:
  - rheumatoid arthritis in adult patients with moderately to severely active disease who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
  - giant cell arteritis in adult patients .
  - polyarticular juvenile idiopathic arthritis in patients 2 years of age and older with active disease.
  - systemic juvenile idiopathic arthritis in patients 2 years of age and older with active disease.
  - chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older.
  - COVID-19 in hospitalized adult patients 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 Tyenne is highly similar to Actemra and that there are no clinically meaningful differences between the biosimilar product and the reference product.
• Tyenne is a biosimilar to Actemra and does not have an interchangeability designation.
• Tyenne is not approved for all the same indications as Actemra. Actemra is approved for the same indications as Tyenne, and also for the treatment of systemic sclerosis-associated interstitial lung disease.
• Tyenne is administered by intravenous infusion or subcutaneous injection.
• The Tyenne product label carries a Boxed Warning for the increased risk of serious infections. Warnings and precautions associated with Tyenne 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.
• Tyenne is the second Actemra biosimilar approved in the United States after the approval of Tofidence (tocilizumab-bavi) in 2023.

Development timeline for Tyenne

Further information

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