The US Food and Drug Administration (FDA) has approved an expanded indication of the intravenous (IV) formulation of tocilizumab-anoh to include in the treatment of cytokine release syndrome (CRS) in adults and pediatric patients ages two years and older.
Tocilizumab‑anoh is a biosimilar of tocilizumab, a monoclonal antibody targeting the interleukin‑6 (IL‑6) receptor. Initial approval of tocilizumab‑anoh was granted by the FDA and European Commission in January and February 2025, respectively.
Following FDA approval of the additional indication for CRS, tocilizumab-anoh IV now aligns with all indications approved for tocilizumab IV in the United States.
“This milestone marks an important step forward in our mission to deliver a safe and effective therapy for CRS,” said Thomas Nusbickel, chief commercial officer at Celltrion USA, which markets tocilizumab-anoh under the brand name AVTOZMA, in a press release. “This FDA approval expands access to high-quality biologics and supports beneficial patient outcomes across multiple therapeutic areas.”
CRS is a side effect in patients receiving chimeric antigen receptor (CAR) T-cell therapy or bispecific antibodies.
