Organon (NYSE: OGN) received U.S. Food and Drug Administration approval to expand the approved uses of TOFIDENCE (tocilizumab-bavi) injection to treat cytokine release syndrome and pediatric COVID-19 patients.

The FDA approved the supplemental Biologics License Application for TOFIDENCE, a biosimilar to ACTEMRA (tocilizumab), to include treatment of adults and pediatric patients 2 years and older with chimeric antigen receptor T cell-induced severe or life-threatening cytokine release syndrome. The approval also covers hospitalized adult and pediatric patients aged 2 years and older with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

TOFIDENCE was the first approved tocilizumab biosimilar in the U.S. market when it launched in May 2024. The drug is already indicated for treating moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis in appropriate patients.

The injection is available in 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20mL presentations in single-dose vials for intravenous infusion after dilution.

Organon acquired the regulatory and commercial rights to TOFIDENCE in the U.S. in 2025, while Bio-Thera Solutions Ltd. maintains manufacturing rights for the U.S. market.

The FDA approval includes warnings about serious infections that may lead to hospitalization or death, including tuberculosis, bacterial, invasive fungal, viral, or other opportunistic infections. Patients require close monitoring for infection signs during and after treatment.