FDA approves tocilizumab-anoh for CRS in patients 2 years and older | Image credit: Contemporary Pediatrics

Tocilizumab-anoh (Avtozma; Celltrion) in IV formulation has another approved indication, following the FDA's approval on August 6, 2025, to treat patients aged 2 years and older with cytokine release syndrome (CRS). According to a press release from Celltrion, tocilizumab-anoh IV now aligns with all indications approved for its reference drug, tocilizumab (Actemra; Genentech). Tocilizumab-anoh, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist.¹

The CRS expanded label approval follows the approval of several indications for tocilizumab-anoh on January 31, 2025. These approvals included indications for polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), and more.²

READ MORE: FDA approves tocilizumab-anoh as biosimilar for multiple diseases

CRS is a condition that occurs when the immune system is highly activated, leading to the rapid and excessive release of cytokines into the bloodstream, stated Celltrion. As this happens, the immune system can cause widespread inflammation and damage to healthy tissue and organs throughout the body. Symptoms can range from flu-like to more severe complications such as low blood pressure, multi-organ failure, and difficulty breathing.¹

“We are proud that [tocilizumab-anoh IV] has now achieved full indication alignment with the reference [tocilizumab-anoh 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, in a statement. "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, Celltrion stated, the IV formulation of AVTOZMA is expected to be available in the United States on August 31, 2025. Celltrion holds a license to market the subcutaneous formulation in the United States commencing on the licensed launch date, which remains confidential.¹

Prior approvals of tocilizumab-anoh (IV and SC formulation)²

• pJIA in patients 2 years and older with active pJIA
• sJIA in patients aged 2 years and older with sJIA
• COVID-19 in hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation
• Giant cell arteritis in adult patients
• Rheumatoid arthritis (RA) in adults with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs

The indications of tocilizumab-anoh, approved in January, were based on a comprehensive data package and totality of evidence that included results from a phase 3 study demonstrating biosimilarity between tocilizumab-anoh and reference tocilizumab in patients with moderate-to-severe active RA.

In the trial, the primary endpoint, change from baseline in disease activity score using 28 joints at week 24, was met. In addition, the final 1-year results supported comparability in secondary efficacy, pharmacokinetics, and safety and immunogenicity results between tocilizumab-anoh and the reference.

Results demonstrated that the biosimilar and reference are "highly similar and have no clinically meaningful differences in terms of efficacy, safety, pharmacokinetics and immunogenicity," stated Celltrion in the announcement.

References:

1. FDA approves expanded indication for AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS). Celltrion. Press release. August 6, 2025. Accessed August 6, 2025.
2. Fitch J. FDA approves tocilizumab-anoh as biosimilar for multiple diseases. Contemporary Pediatrics. February 3, 2025. Accessed August 6, 2025. https://www.contemporarypediatrics.com/view/fda-approves-tocilizumab-anoh-as-biosimilar-for-multiple-diseases