Tofidence FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 2, 2023.
FDA Approved: Yes (First approved September 29, 2023)
Brand name: Tofidence
Generic name: tocilizumab-bavi
Dosage form: Injection
Company: Biogen Inc.
Treatment for: Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Juvenile Idiopathic Arthritis
Tofidence (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist biosimilar to Actemra indicated for treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
- Tofidence 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).
- 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. - The FDA approval of Tofidence was based on clinical data that demonstrated that Tofidence is highly similar to Actemra and that there are no clinically meaningful differences between the biosimilar product and the reference product.
- Tofidence is a biosimilar to Actemra and does not have an interchangeability designation.
- Tofidence is not approved for all the same indications as Actemra. Actemra is approved for the same indications as Tofidence, and for the treatment of giant cell arteritis, systemic sclerosis-associated interstitial lung disease, cytokine release syndrome, and hospitalized adult patients with COVID-19.
- Tofidence is administered by intravenous infusion over one hour every 4 weeks for rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, and every 2 weeks for systemic juvenile idiopathic arthritis.
- The Tofidence product label carries a Boxed Warning for the increased risk of serious infections. Warnings and precautions associated with Tofidence 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, and increased alanine transaminase (ALT).
- Tofidence is the first tocilizumab biosimilar approved in the United States.
Development timeline for Tofidence
Further information
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