Organon (OGN) said Wednesday that the US Food and Drug Administration has approved a supplemental Biologics License Application expanding the indications for Tofidence, a biosimilar to Actemra.

The expanded label covers treatment of cytokine release syndrome after CAR T-cell therapy and use in hospitalized COVID-19 patients aged 2 and older requiring oxygen support or ventilatory assistance, the company added.

Organon said the expanded approval helps improve access to high-cost biologic treatments, but also noted that the drug is associated with serious safety risks, including infections such as tuberculosis and potential liver injury.

Tofidence was first approved in 2024 and is already indicated for rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis, it added.