FDA Grants Approval to Celltrion for Expanded Indication of Actemra Biosimilar to Treat CRS

Celltrion announced on Aug. 6, 2025 that FDA has approved its application for an expanded indication of tocilizumab-anoh (brand name Avtozma), its intravenous (IV) therapy, to include the treatment of cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older (1). Tocilizumab-anoh is a biosimilar to Actemra (tocilizumab), the originator biologic from Genentech, a member of the Roche Group. Actemra was originally approved by FDA in January 2010 (2).

With this additional approval from FDA for the CRS indication, Celltrion’s tocilizumab-anoh IV now aligns with all indications for which Genentech’s originator tocilizumab IV is approved in the United States. Tocilizumab-anoh in IV formulation originally received FDA approval in January 2025 for treating multiple inflammatory indications, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and coronavirus COVID-19 (3).

"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, in a company press release (1). "This FDA approval expands access to high-quality biologics and supports beneficial patient outcomes across multiple therapeutic areas."

About CRS

CRS is a potentially life-threatening condition. It occurs when the immune system is highly activated, which leads to rapid and excessive release of cytokines into the bloodstream—a cytokine storm. During a cytokine storm, the overactivated immune system can lead to widespread inflammation and can cause damage to healthy tissue and organs throughout the body. Symptoms range from mild, flu-like symptoms to more severe complications, including low blood pressure, difficulty breathing, and multi-organ failure (4).

CRS is a recognized complication of certain T-cell-engaging (TCE) immunotherapies. Such therapies include chimeric antigen T-cell and bispecific therapies. CRS can occur from a severe infection, such as COVID-19. Multiple myeloma drugs that may cause CRS include:

• idecabtagene vicleucel (brand name Abecma)
• ciltacabtagene autoleucel (brand name Carvykti)
• elranatamab-bcmm (brand name Elrexfio)
• talqueta
• teclistamab-cqyv (brand name Tecvayli) (4).

Settlement between Celltrion and Genentech

In compliance with a patent settlement agreement between Celltrion and Genentech, the IV formulation of tocilizumab-anoh is expected to be available in the US market on Aug. 31, 2025. Celltrion holds a license to market a subcutaneous formulation in the US starting on a licensed launch date, which has not been disclosed.

About tocilizumab-anoh

Tocilizumab-anoh is a recombinant humanized monoclonal antibody that acts as an interleukin 6 receptor antagonist. FDA’s approval was based on data from a global Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics, safety, and immunogenicity of CT-P47 (tocilizumab-anoh’s designation during pipeline development) (3) in comparison to the reference biologic, tocilizumab. The biosimilar also received approval by the European Commission in February 2025.

References

1. Celltrion. FDA Approves Expanded Indication for AVTOZMA (tocilizumab-anoh) Intravenous (IV) Formulation in Cytokine Release Syndrome (CRS). Press Release. Aug. 7, 2025.
2. FDA. Actemra Approval Letter. fda.gov, Jan. 8, 2010 (accessed Aug. 8, 2025). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125276
3. Celltrion. US FDA approves Celltrion's AVTOZMA (tocilizumab-anoh), a Biosimilar to ACTEMRA. Press Release. Jan. 30, 2025.
4. International Myeloma Foundation. What is Cytokine Release Syndrome (CRS)? myeloma.org (accessed Aug. 8, 2025).