FDA Expands TOFIDENCE Indications to Include CAR-T Cytokine Release Syndrome and Pediatric COVID-19
Key Insights
Organon received FDA approval for a supplemental Biologics License Application expanding TOFIDENCE (tocilizumab-bavi) indications to include CAR T-cell-induced CRS and COVID-19 (search) in hospitalized patients aged 2 and older.
TOFIDENCE, the first tocilizumab biosimilar entrant in the US market, was originally launched in May 2024 for rheumatoid arthritis (search), giant cell arteritis (search), and juvenile idiopathic arthritis.
The expanded approval addresses critical unmet needs, including CRS, a serious side effect of CAR-T therapies, and may help reduce the affordability burden of high-cost brand biologics on the healthcare system.
Organon (NYSE: OGN) announced on June 10, 2026, that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for TOFIDENCE (tocilizumab-bavi) injection for intravenous use, a biosimilar to ACTEMRA (tocilizumab). The approval expands the label to include two new indications: the treatment of adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (search) (CRS), and the treatment of hospitalized adult and pediatric patients aged 2 years and older with coronavirus disease 2019 (COVID-19 (search)) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
"The approval of these new indications for TOFIDENCE is a vital step forward in expanding access to treatment options that address critical needs, including for patients facing CRS, a serious side effect of CAR-T therapies," said Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon. "In the US, biosimilar adoption may help reduce the affordability burden of high-cost brand biologics on the health care system. By expanding the use of TOFIDENCE, we continue to advance our biosimilars portfolio and our commitment to broadening access to high-quality treatment options for patients in need."
A Growing Biosimilar Portfolio
TOFIDENCE, the first approved tocilizumab biosimilar entrant in the US market, was launched in May 2024 and is already indicated for the treatment of moderately to severely active rheumatoid arthritis (search) (RA) in adults with inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs), giant cell arteritis (search) (GCA) in adults, active polyarticular juvenile idiopathic arthritis (search) (PJIA) in patients 2 years and older, and active systemic juvenile idiopathic arthritis (search) (SJIA) in patients 2 years and older. The product is an interleukin-6 (IL-6) receptor antagonist available in three presentations: 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), and 400 mg/20 mL (20 mg/mL), all in single-dose vials for further dilution prior to intravenous infusion.
Organon acquired the regulatory and commercial rights to TOFIDENCE in the US in 2025. Bio-Thera Solutions (search) Ltd., the product developer, maintains manufacturing rights for TOFIDENCE for the US market.
Safety Considerations and Boxed Warning
TOFIDENCE carries a Boxed Warning for the risk of serious infections. Patients treated with tocilizumab products, including TOFIDENCE, are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. Reported infections include active tuberculosis (which may present with pulmonary or extrapulmonary disease), invasive fungal infections including candidiasis, aspergillosis, and pneumocystis, as well as bacterial and viral infections due to opportunistic pathogens.
TOFIDENCE should not be administered to patients with an active infection, including localized infections. If a serious infection develops, treatment should be interrupted until the infection is controlled. Patients should be closely monitored for signs and symptoms of infection during and after treatment, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Additional warnings and precautions include gastrointestinal perforations, hepatotoxicity, neutropenia, thrombocytopenia, lipid abnormalities, hypersensitivity reactions including anaphylaxis, and demyelinating disorders. The most common adverse reactions, occurring at an incidence of at least 5%, include upper respiratory tract infection, nasopharyngitis, headache, hypertension, and increased ALT.
TOFIDENCE is contraindicated in patients with known hypersensitivity to tocilizumab products. Prescribers should exercise caution when coadministering TOFIDENCE with CYP3A4 substrate drugs where a decrease in effectiveness is undesirable, such as oral contraceptives, lovastatin, and atorvastatin. Avoid use of live vaccines concurrently with TOFIDENCE, as clinical safety has not been established.