Celltrion has received US Food and Drug Administration approval for an expanded indication of AVTOZMA (tocilizumab-anoh) intravenous infusion, now authorised to treat cytokine release syndrome (CRS) in adults and children aged 2 years and older.
The decision brings AVTOZMA IV into full alignment with all approved indications for ACTEMRA IV in the US. AVTOZMA was initially approved in January 2025 for multiple inflammatory conditions including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.
CRS is a potentially life-threatening condition triggered by excessive immune activation. It leads to a rapid release of cytokines into the bloodstream, causing inflammation and damage to healthy tissues.
Symptoms can range from mild flu-like effects to severe complications such as low blood pressure, breathing difficulties and multi-organ failure.
The expanded approval supports broader access to biosimilar therapies for patients affected by CRS. Celltrion emphasised the significance of the milestone in advancing treatment options for immune-related conditions.
Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, said: “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.”
In line with a patent settlement agreement with Genentech, AVTOZMA IV is expected to become available in the US on 31 August 2025. Celltrion also holds a licence to market the subcutaneous formulation, although the launch date remains confidential.
