FDA approves expanded indication for AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS)

Korea Herald

3 days ago

INCHEON, South Korea, Aug. 6, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. 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 pediatric 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. [1]
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). [1]
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. [2]
"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."
In accordance with the patent settlement agreement with Genentech, the IV formulation of AVTOZMA is expected to be available in the U.S. on August 31, 2025. Celltrion holds a license to market the subcutaneous formulation in the U.S. commencing on the licensed launch date, which remains confidential.
Notes to Editors:
AVTOZMA ® (tocilizumab-anoh), containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of CT-P47 compared to reference tocilizumab. AVTOZMA received approval from the U.S. Food and Drug Administration (FDA) and European Commission (EC) in January and February 2025, respectively.
INDICATION
AVTOZMA ® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS INFECTIONS
AVTOZMA ® and other tocilizumab products may increase the risk of serious infections, potentially leading to hospitalization or death, especially in patients using concurrent immunosuppressants.
If a serious infection develops, interrupt AVTOZMA until the infection is controlled. Reported infections include:
Monitor patients for signs of infection, including TB, during and after AVTOZMA treatment.
Contraindications: Known hypersensitivity to tocilizumab products.
Serious Infections. Serious and sometimes fatal infections have been reported with AVTOZMA. Do not use during active infections, including localized infections. Discontinue AVTOZMA if a serious infection occurs and resume only once controlled.
Gastrointestinal (GI) Perforation. Gastrointestinal perforations, often linked to diverticulitis, have been reported with tocilizumab. Use AVTOZMA cautiously in high-risk patients and promptly evaluate new abdominal symptoms for early detection and management.
Hepatoxicity. Monitor for hepatic injury signs. Avoid AVTOZMA if ALT/ AST >1.5x ULN (RA/GCA) or >10x ULN (COVID-19); discontinue if ALT/AST >5x ULN or symptoms of liver disease develop.
Changes in Laboratory Parameters. Monitor neutrophils, platelets, liver enzymes, and lipids due to potential treatment-related changes; avoid initiating AVTOZMA in patients with critically low ANC or platelet counts.
Immunosuppression. The impact of AVTOZMA on malignancy development is unknown, but it may increase risk as an immunosuppressant.
Hypersensitivity Reactions, including anaphylaxis, and death, have occurred; administer IV infusions with anaphylaxis management support, discontinue permanently if reactions occur, and avoid use in patients with known hypersensitivity.
Demyelinating Disorders. The impact of tocilizumab on demyelinating disorders is unknown, but rare cases were reported; monitor symptoms and use caution with preexisting or recent disorders.
Active Hepatic Disease and Hepatic Impairment. Treatment with AVTOZMA is not recommended.
Live Vaccines. Avoid concurrent use with AVTOZMA.
Adverse Reactions (≥5%) include upper respiratory tract infections, nasopharyngitis, headache, hypertension, elevated ALT, and injection site reactions.
About Celltrion
Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 countries. Celltrion has seven biosimilars approved by the U.S. FDA: INFLECTRA ® (infliximab-dyyb), TRUXIMA ® (rituximab-abbs), HERZUMA ® (trastuzumab-pkrb), VEGZELMA ® (bevacizumab-adcd), YUFLYMA ® (adalimumab-aaty), STEQEYMA ® (ustekinumab-stba), and AVTOZMA ® (tocilizumab-anoh), as well as novel biologic ZYMFENTRA ® (infliximab-dyyb). For more information, please visit https://www.celltrion.com/en-us.
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