FDA Expands Avtozma to Include Cytokine Release Syndrome Treatment for Adults and Children

The FDA recently expanded the approved uses of Avtozma (tocilizumab-anoh) intravenous (IV) infusion to include treatment of cytokine release syndrome (CRS) in adults and pediatric patients aged 2 years and older.

This expansion marks a significant development in managing a potentially life-threatening immune condition affecting patients undergoing certain advanced therapies, especially children receiving chimeric antigen receptor (CAR) T-cell treatments.

Originally approved earlier this year for multiple inflammatory conditions, including rheumatoid arthritis, giant cell arteritis, juvenile idiopathic arthritis and COVID-19-related inflammation, Avtozma now aligns fully with the FDA-approved indications of its biosimilar, Actemra.

This approval is an additional treatment option for CRS, a serious complication causing excessive immune activation and cytokine overproduction.

CRS is a hyperinflammatory state triggered by an overactive immune system, also known as a “cytokine storm.”

It can lead to widespread inflammation and damage to tissues and organs throughout the body. Symptoms can range from mild flu-like discomfort to life-threatening conditions such as low blood pressure, respiratory distress, and multi-organ failure.

CRS is especially common and severe in patients undergoing CAR T-cell therapies, which use genetically modified immune cells to target cancer. Pediatric patients, in particular, are at increased risk.

A review published in the Journal for ImmunoTherapy of Cancer reported that CRS occurred in 100% of children treated with CD19-targeted CAR T cells in one trial and 76% in another. The higher incidence in children may relate to the immature immune system or higher cell doses used during treatment.

Avtozma contains tocilizumab, a recombinant humanized monoclonal antibody that blocks the interleukin-6 (IL-6) receptor. IL-6 is a key cytokine involved in immune system activation and inflammation. By inhibiting IL-6 signaling, avtozma helps reduce the dangerous immune overreaction seen in CRS.

The FDA’s expanded approval is based off of comprehensive data from global phase III clinical trials demonstrating the drug’s efficacy, safety and similarity to Avtozma.

As a biosimilar to Actemra, Avtozma offers the potential to improve patient access through cost savings enabled by biosimilar competition. While exact pricing for Avtozma has not been publicly announced, biosimilar launches have historically resulted in significant market share capture and cost reductions.

According to Samsung Bioepis’ First Quarter 2025 Biosimilar Market Report, biosimilars have achieved approximately 53% market share in their categories and reduced average drug costs by 53% after five years of competition.

In addition, a report from Biosimilars Review and Report indicated that tocilizumab biosimilars were priced around 35% below the average sales price of Actemra at that time.

Without insurance, intravenous tocilizumab solutions can cost between roughly $500 and over $2,600 per vial, depending on dosage, according to drugs.com. For some patients, co-pay assistance programs can reduce out-of-pocket costs significantly.

For example, Actemra’s co-pay program caps patient payments as low as $5 per treatment for eligible commercially insured individuals, according to the drug’s website.

The launch of Avtozma’s IV formulation in the U.S. is expected on August 31, 2025, following a patent settlement agreement with Genentech, the maker of Actemra. Celltrion also holds the rights to market a subcutaneous formulation, with launch details pending.

By providing an FDA-approved, biosimilar treatment option for both adults and children, the approval indicates the improvement of clinical outcomes and potentially increases access through biosimilar competition.