Celltrion, Inc. has announced that the US Food and Drug Administration (FDA) has approved an expanded indication of the intravenous (IV) formulation of AVTOZMA (tocilizumab-anoh) to include the treatment of cytokine release syndrome (CRS) in adults and paediatric patients aged 2 years and older. Following FDA approval of the additional indication for CRS, AVTOZMA IV now aligns with all indications approved for ACTEMRA IV in the United States.

Earlier this year, the FDA approved AVTOZMA as a biosimilar to ACTEMRA in IV formulations for the treatment of multiple diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (COVID-19), the company said in a statement.

CRS is a potentially life-threatening condition that occurs when the immune system is highly activated, leading to the rapid and excessive release of cytokines into the bloodstream. During a cytokine storm, the overactivated immune system can cause widespread inflammation and damage to healthy tissue and organs throughout the body, with symptoms ranging from mild, flu-like symptoms to more severe complications such as low blood pressure, difficulty breathing, and multi-organ failure.

“We are proud that AVTOZMA IV has now achieved full indication alignment with the reference ACTEMRA IV. 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. “This FDA approval expands access to high-quality biologics and supports beneficial patient outcomes across multiple therapeutic areas.”