FDA approved Tofidence (tocilizumab-bavi) for Multiple Inflammatory Conditions and COVID-19FDA approved new biosimilar drug Tofidence for arthritis and COVID-19.

FDA From the archive Source published September 29, 2023 Summary added May 26, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Tofidence as a biosimilar option for IL-6 receptor antagonism in RA, GCA, PJIA, SJIA, and COVID-19.

The FDA has approved Tofidence (tocilizumab-bavi), a biosimilar to tocilizumab, for multiple indications including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19 in hospitalized adults. This approval provides an additional treatment option for patients with these conditions. Tofidence is an interleukin-6 (IL-6) receptor antagonist that can be used alone or with methotrexate and other non-biologic DMARDs. The approval covers both adult and pediatric populations aged 2 years and older for the juvenile arthritis indications.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Tofidence (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist. It binds to both soluble and membrane-bound IL-6 receptors, inhibiting IL-6-mediated signaling.

Indication & Patient Population

Tofidence is indicated for: - Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more DMARDs. - Giant Cell Arteritis (GCA): Adult patients with GCA. - Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2 years of age and older with active PJIA. - Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2 years of age and older with active SJIA. - Coronavirus Disease 2019 (COVID-19): Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

Dosing & Administration

For RA: Starting dose 4 mg/kg IV every 4 weeks, increase to 8 mg/kg every 4 weeks based on clinical response. For GCA: 6 mg/kg IV every 4 weeks with glucocorticoid taper. For PJIA: <30 kg: 10 mg/kg IV every 4 weeks; ≥30 kg: 8 mg/kg IV every 4 weeks. For SJIA: <30 kg: 12 mg/kg IV every 2 weeks; ≥30 kg: 8 mg/kg IV every 2 weeks. For COVID-19: 8 mg/kg IV single infusion over 60 minutes. Doses exceeding 800 mg per infusion not recommended for RA or COVID-19; exceeding 600 mg per infusion not recommended for GCA. Do not initiate if ANC <2000/mm3 (RA/GCA/PJIA/SJIA) or <1000/mm3 (COVID-19), platelets <100,000/mm3 (RA/GCA/PJIA/SJIA) or <50,000/mm3 (COVID-19), or ALT/AST >1.5x ULN (RA/GCA/PJIA/SJIA) or >10x ULN (COVID-19).

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Tofidence is a biosimilar to tocilizumab, providing an alternative for patients requiring IL-6 receptor blockade across multiple indications. It may be used alone or with methotrexate and other non-biologic DMARDs for RA, PJIA, and SJIA. Avoid concomitant use with biological DMARDs due to increased immunosuppression risk.

The FDA has approved a new drug called Tofidence (tocilizumab-bavi) for several conditions. It is a biosimilar, which means it is highly similar to an already approved biologic drug. Tofidence treats rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19 in hospitalized adults. It works by blocking a protein called interleukin-6 (IL-6) that causes inflammation.

Tofidence can be used alone or with methotrexate and other non-biologic disease-modifying antirheumatic drugs (DMARDs). For the juvenile arthritis indications, it is approved for children aged 2 years and older. This approval provides an additional treatment option for patients with these conditions.

This approval means that patients now have another choice when considering treatment. However, it is important to remember that every patient is different. What works for one person may not work for another. If you or a loved one has one of these conditions, talk to your doctor about whether Tofidence might be a good option.

While this is good news, it is not a cure. Patients should continue to follow their doctor's advice and discuss any concerns about their treatment plan. Always consult your healthcare provider before making changes to your medications.

What this means for you:

Tofidence is a new biosimilar option for arthritis and COVID-19; talk to your doctor if it might be right for you.

Study Details

Study typeFda approval

PublishedSep 2023

View Original Abstract ↓

1 INDICATIONS AND USAGE TOFIDENCE™ (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) 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). Giant Cell Arteritis (GCA) ( 1.2 ) Adult patients with giant cell arteritis. Polyarticular Juvenile Idiopathic Arthritis (PJIA) ( 1.3 ) Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) ( 1.4 ) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. Coronavirus Disease 2019 (COVID-19) ( 1.5 ) Hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). 1.1 Rheumatoid Arthritis (RA) 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). 1.2 Giant Cell Arteritis (GCA) TOFIDENCE™ (tocilizumab-bavi) is indicated for the treatment of giant cell arteritis (GCA) in adult patients. 1.3 Polyarticular Juvenile Idiopathic Arthritis (PJIA) TOFIDENCE™ (tocilizumab-bavi) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. 1.4 Systemic Juvenile Idiopathic Arthritis (SJIA) TOFIDENCE™ (tocilizumab-bavi) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. 1.5 Coronavirus Disease 2019 (COVID-19) 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).

FDA approved Tofidence (tocilizumab-bavi) for Multiple Inflammatory Conditions and COVID-19FDA approved new biosimilar drug Tofidence for arthritis and COVID-19.

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FDA approved Tofidence (tocilizumab-bavi) for Multiple Inflammatory Conditions and COVID-19FDA approved new biosimilar drug Tofidence for arthritis and COVID-19.

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