Tocilizumab-bavi (TOFIDENCE)

概览

TOFIDENCE (tocilizumab-bavi) is the first tocilizumab biosimilar approved in the US market. It is an IL-6 receptor antagonist biosimilar to ACTEMRA (tocilizumab), developed by Bio-Thera Solutions and commercialized by Organon in the US. Originally approved for rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis, its indications were expanded in June 2026 to include CAR T-cell-induced cytokine release syndrome and COVID-19 in hospitalized patients aged 2 and older.

适应症

TOFIDENCE (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist indicated for: 1. Rheumatoid Arthritis (RA): 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). 2. Giant Cell Arteritis (GCA): Treatment of giant cell arteritis in adult patients. 3. Polyarticular Juvenile Idiopathic Arthritis (PJIA): Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. 4. Systemic Juvenile Idiopathic Arthritis (SJIA): Treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. 5. Cytokine Release Syndrome (CRS): Treatment of 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. 6. Coronavirus Disease 2019 (COVID-19): Treatment of coronavirus disease 2019 in hospitalized adult and pediatric patients aged 2 years and older who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

• Rheumatoid Arthritis
• Giant Cell Arteritis
• Polyarticular Juvenile Idiopathic Arthritis
• Systemic Juvenile Idiopathic Arthritis
• Cytokine Release Syndrome (CAR T-cell-induced)
• Coronavirus Disease 2019 (COVID-19)