These highlights do not include all the information needed to use TOFIDENCE safely and effectively. See full prescribing information for TOFIDENCE. TOFIDENCE™ (tocilizumab-bavi) injection, for intravenous use Initial U.S. Approval: 2023 TOFIDENCE (tocilizumab-bavi) is biosimilar 1 to ACTEMRA (tocilizumab). 1 - Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of TOFIDENCE has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

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These highlights do not include all the information needed to use TOFIDENCE safely and effectively. See full prescribing information for TOFIDENCE. TOFIDENCE™ (tocilizumab-bavi) injection, for intravenous use Initial U.S. Approval: 2023 TOFIDENCE (tocilizumab-bavi) is biosimilar 1 to ACTEMRA (tocilizumab). 1 - Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of TOFIDENCE has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

Medication label

Why this: Advisory · dailymed-prescription

TOFIDENCE (tocilizumab-bavi) 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). TOFIDENCE™ (tocilizumab-bavi) is indicated for the treatment of giant cell arteritis (GCA) in adult patients. TOFIDENCE™ (tocilizumab-bavi) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. TOFIDENCE™ (tocilizumab-bavi) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. TOFIDENCE™ (tocilizumab-bavi) is indicated for the treatment of coronavirus disease 2019 (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).

generic_name: tocilizumab
product_names: Tocilizumab
ndc: 64406-022, 64406-023, 64406-022-01, 64406-023-01, 64406-024, 64406-024-01
group: drugs
license: us-gov-pd
attribution: Courtesy of the National Library of Medicine
reviewed: 2026-09-18
language: en