FDA OKs Intravenous Tocilizumab Biosimilar in Cytokine Release Syndrome

The FDA originally approved tocilizumab-anoh via intravenous and subcutaneous administration across multiple indications in January 2025.

The FDA has approved an expanded indication for an intravenous formulation of tocilizumab-anoh (Avtozma; CT-P47), a biosimilar of tocilizumab (Actemra), for the management of cytokine release syndrome (CRS), according to a press release from the developer, Celltrion.1

Based on the agency’s latest approval, all indications for intravenous tocilizumab-anoh now align with those approved for reference intravenous tocilizumab in the US. Following a patient settlement agreement with Genentech, the intravenous formulation of tocilizumab-anoh is anticipated to launch in the US on August 31, 2025.

“We are proud that [intravenous tocilizumab-anoh] has now achieved full indication alignment with the reference [intravenous tocilizumab]. This milestone marks an important step forward in our mission to deliver a safe and effective therapy for CRS,” Thomas Nusbickel, chief commercial officer at Celltrion USA, stated in the press release.1 “This FDA approval expands access to high-quality biologics and supports beneficial patient outcomes across multiple therapeutic areas.”

Developers engineered tocilizumab-anoh as a recombinant humanized monoclonal antibody that functions as an interleukin 6 (IL-6) receptor antagonist.

The FDA originally approved tocilizumab-anoh via intravenous and subcutaneous administration across multiple indications in January 2025.2 The agency indicated the agent for the management of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. The agency based its decision on findings from a comprehensive data package, which included results from a phase 3 trial (NCT05489224) assessing the biosimilarity of tocilizumab-anoh compared with reference tocilizumab.

Phase 3 data demonstrated that tocilizumab-anoh reached the trial’s primary end point of changes in disease activity score using 28 joints (DAS28)–erythrocyte sedimentation rate (ESR) criteria at 24 weeks vs baseline. Additionally, final 1-year data highlighted no clinically meaningful differences in efficacy, pharmacokinetic, safety, and immunogenicity outcomes among patients who received tocilizumab-anoh or the reference agent.

“Introducing both [intravenous] and [subcutaneous] formulations of [tocilizumab-anoh] 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 health care providers,” Nusbickel stated in a press release on the original FDA approval.2

In the double-blind phase 3 study, patients were randomly assigned to receive tocilizumab-anoh or reference tocilizumab at 8 mg/kg intravenously every 4 weeks.3 The trial’s primary end point was the mean change in DAS28 per ESR from baseline to week 24. Secondary end points included mean changes in DAS28 per ESR from baseline to week 32 and ACR20, ACR50, and ACR70 responses at weeks 24 and 32.

Patients 18 to 75 years old with a diagnosis of rheumatoid arthritis per 2010 ACR/EULAR criteria for a minimum of 24 weeks before beginning study treatment were eligible for enrollment. Those with prior use of targeted synthetic DMARDs for rheumatoid arthritis and/or an IL-6 inhibitor for any reason were ineligible for study entry. Having prior receipt of more than 1 biologic agent for the management of rheumatoid arthritis was also grounds for exclusion.

Safety information for tocilizumab-anoh highlights a potentially higher risk of serious infections that may cause hospitalization or death, especially among those who are receiving concurrent immunosuppressants. The labelling for the agent also includes warnings related to gastrointestinal perforation, hepatoxicity, changes in laboratory parameters, immunosuppression, and demyelinating disorders. Additionally, other potential toxicities associated with the agent include upper respiratory tract infections, nasopharyngitis, headache, hypertension, elevated alanine aminotransferase, and injection site reactions.

References

1. FDA approves expanded indication for AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS). News release. Celltrion. August 6, 2025. Accessed August 6, 2025. https://tinyurl.com/36t9pa2m
2. U.S. FDA approves Celltrion's AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA®. News release. Celltrion. January 30, 2025. Accessed August 6, 2025. https://tinyurl.com/2s4bc53t
3. A study to compare efficacy and safety of CT-P47 and RoActemra in patients with rheumatoid arthritis. ClinicalTrials.gov. Updated October 8, 2024. Accessed August 6, 2025. https://tinyurl.com/57db28x7