The latest news about Avtozma (tocilizumab-anoh) in 2025

The U.S. Food and Drug Administration (FDA) has approved Avtozma (tocilizumab-anoh) as a biosimilar of Actemra (tocilizumab), available in both intravenous (IV) and subcutaneous (SC) dosage forms. Avtozma, formerly known as CT-P47, is an interleukin-6 receptor antagonist indicated for the treatment of a variety of conditions, including moderately to severely active rheumatoid arthritis, adult giant cell arteritis, patients 2 years and older with active polyarticular juvenile idiopathic arthritis or systemic juvenile idiopathic arthritis, as well as hospitalized adult patients with COVID-19 who require supplemental oxygen or mechanical ventilation.

The approval was based on a comprehensive review of scientific evidence demonstrating a high degree of similarity between Avtozma and Actemra This includes data from a Phase III study that evaluated the efficacy and safety of tocilizumab-anoh versus the reference drug tocilizumab (r-TCZ) in 471 patients with moderately to severely active rheumatoid arthritis.

In the first treatment phase of the study, participants were randomized into two groups and received intravenous injections of tocilizumab-anoh or r-TCZ through week 20. In the second phase before Week 24, patients who received r-TCZ were again randomized to either continue the drug or switch to tocilizumab-anoh until Week 48. The co-primary endpoint is change in disease activity score using erythrocyte sedimentation rate (DAS28-ESR) assessment at weeks 12 and 24.

The results showed that the estimated treatment differences of DAS28-ESR were -0.01 and -0.10 at weeks 12 and 24, respectively, indicating similar treatment effects between the two. In addition, Avtozma and the reference product also showed comparability in terms of pharmacokinetics, safety and immunogenicity, and there were no safety issues in the sustained efficacy when switching from r-TCZ to Avtozma.

Avtozma is available as a preservative-free solution in 20 mg/mL single-dose vials (80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL) for intravenous infusion, and 162 mg/0.9 mL single-dose prefilled syringes and auto-injectors for subcutaneous injection. This approval provides patients with more flexible treatment options.

Reference materials:https://www.rheumatologyadvisor.com/news/fda-approves-tocilizumab-biosimilar-avtozma/