FDA Approves Third Tocilizumab Biosimilar

The US Food and Drug Administration (FDA) has approved Avtozma (tocilizumab-anoh) as a biosimilar of the original reference biologic tocilizumab (Actemra), according to a January 30 announcement from its manufacturer, Celltrion.

Avtozma, an anti-interleukin 6 receptor antagonist, is approved for all of the same indications as reference tocilizumab (Actemra) — rheumatoid arthritis (RA), giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and coronavirus disease (COVID-19) — except for systemic sclerosis-associated interstitial lung disease.

The biologic is the third FDA-approved biosimilar of Actemra and will be available in both intravenous (IV) and subcutaneous (SC) formulations at the same dosages as Actemra. The dosage options for the IV formulation are 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL), and for the SC route, 162 mg/0.9 mL in a single-dose prefilled syringe or single-dose autoinjector 

The approval is based on “a comprehensive data package and the totality of evidence, including the results from a phase III study demonstrating biosimilarity between Avtozma and reference tocilizumab in patients with moderate to severe active RA. The primary endpoint was met in terms of change from baseline in disease activity score using 28 joints-ESR [erythrocyte sedimentation rate] at week 24, and the final 1-year results supported comparability in secondary efficacy, pharmacokinetic, safety and immunogenicity results between Avtozma and reference tocilizumab. The clinical results demonstrated that Avtozma and its reference tocilizumab are highly similar and have no clinically meaningful differences in terms of efficacy, safety, pharmacokinetics, and immunogenicity,” according to the announcement.

The other two FDA-approved tocilizumab biosimilars, tocilizumab-bavi (Tofidence) and tocilizumab-aazg (Tyenne), were approved September 29, 2023, and March 7, 2024, respectively.

Full prescribing information for Avtozma is available here.