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Celltrion announced Avtozma received approval by FDA for an expanded indication of the intravenous (IV) formulation of the biosimilar for the treatment of cytokine release syndrome (CRS) in adult and pediatric patients aged 2 years and older. FDA’s approval of additional indication for CRS in Avtozma IV now aligns its approved indications with Actemra IV within the U.S.

Thomas Nusbickel, chief commercial officer at Celltrion U.S., touched on Avtozma’s approval for expanded indication, saying, "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. This FDA approval expands access to high-quality biologics and supports beneficial patient outcomes across multiple therapeutic areas."¹

Approving Avtozma

Back in February of this year, Avtozma received FDA approval as both an intravenous and subcutaneous formulation, acting as a biosimilar to Actemra, for the treatment of rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), and coronavirus disease.

Nusbickel noted the importance of the approval for both formulations, while also touching on the impact on the company’s goals, saying, "Introducing both IV and SC formulations of Avtozma provides flexibility and a wider range of treatment options. This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and healthcare providers. Our goal is to provide safe and effective alternatives and ensure appropriate access so plan sponsors can address unique population needs."²

The decision for the approval was backed by data and evidence from a phase III study looking into the bio similarities between Avtozma and reference tocilizumab in patients suffering from RA. Avtozma reached its primary endpoint in terms of change from baseline in disease activity score using 28 joints at week 24, and the final year end results supporting comparability in secondary efficiency, pharmacokinetic, safety, and immunogenicity results between Avtozma and reference tocilizumab.

Tested treatment

Avtozma contains the active ingredient tocilizumab a recombinant humanized monoclonal antibody acting as an interleukin-6 receptor antagonist for the treatment of RA, GCA, pJIA, sJIA, CRS, and Covid-19. The recent approval of Avtozma focuses on treatment of CRS, a potentially life-threating condition that occurs when the immune system is highly activated which leads to the accelerated and excessive release of cytokines into the bloodstream. During this rapid release in a cytokine storm, an overactivated immune system causes extensive inflammation and damages health tissue and organs within the body. Symptoms of CRS can vary between patients with reports of symptoms ranging from mild flu-like symptoms to low blood pressure, breathing difficulties, and organ failure.

Avtozma’s availability

IV formulation of Avtozma is expected to become available in the U.S. on August 31, 2025, in accordance with the patent settlement agreement with Genentech. Notably, Celltrion’s license for Avtozma’s subcutaneous formulation in the U.S. will be initiated upon a launch date which has yet to be revealed.

Sources

1. FDA approves expanded indication for AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS) Celltrion August 6, 2025 https://www.prnewswire.com/news-releases/fda-approves-expanded-indication-for-avtozma-tocilizumab-anoh-intravenous-iv-formulation-in-cytokine-release-syndrome-crs-302522996.html
2. U.S. FDA approves Celltrion's AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA® Celltrion February 11, 2025 https://www.prnewswire.com/news-releases/us-fda-approves-celltrions-avtozma-tocilizumab-anoh-a-biosimilar-to-actemra-302364951.html