US healthcare company Organon (NYSE:OGN) on Wednesday announced US Food and Drug Administration (FDA) approval of a supplemental Biologics License Application for TOFIDENCE (tocilizumab-bavi), an intravenous biosimilar to ACTEMRA (tocilizumab).

This approval expands indications to include treatment of severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients aged 2 years and older following CAR T-cell therapy. It also extends use to hospitalised adults and paediatric patients aged 2 years and older with COVID-19 requiring oxygen support, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) while receiving systemic corticosteroids.

TOFIDENCE, the first tocilizumab biosimilar approved in the United States, was launched in May 2024 and is already indicated for multiple autoimmune and inflammatory conditions, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

The product is supplied in multiple single-dose vial presentations for intravenous infusion following dilution.

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