FDA approves Tofidence for cytokine release syndrome and pediatric COVID-19

FDA has approved expanded indications for Tofidence (tocilizumab-bavi), a biosimilar to Actemra (tocilizumab), for adults and children aged 2 years and older with CAR T cell–induced severe or life-threatening cytokine release syndrome (CRS) and for hospitalized adults and children aged 2 years and older with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Tocilizumab is a key treatment for CRS and remains part of guideline-supported management for selected patients hospitalized with severe COVID-19. The expanded approval provides an additional biosimilar option in settings where rapid access to treatment is critical.

Tofidence is the first FDA-approved tocilizumab biosimilar and is already approved for rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. The new indications broaden access to IL-6 receptor blockade in both oncology- and infection-related inflammatory conditions.

Clinicians should remain mindful of the safety profile of tocilizumab products. Serious infections, including tuberculosis, bacterial infections, invasive fungal infections, and other opportunistic infections, remain important risks. Additional warnings include hepatotoxicity, neutropenia, thrombocytopenia, gastrointestinal perforation, hypersensitivity reactions, and lipid abnormalities.

“In the US, biosimilar adoption may help reduce the affordability burden of high-cost brand biologics on the health care system,” said Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon.

Source: Organon. 2026 June 10. [Press release]. Organon Secures US Food and Drug Administration Approval Expanding Indications for Tofidence (tocilizumab-bavi) in Cytokine Release Syndrome and Pediatric COVID-19