AVTOZMA (tocilizumab-anoh) demonstrated biosimilarity to reference tocilizumab in patients with moderate to severe rheumatoid arthritis, with study results supporting comparability in efficacy, pharmacokinetics, safety, and immunogenicity.
The U.S. Food and Drug Administration approved AVTOZMA, a biosimilar to ACTEMRA, for the treatment of rheumatoid arthritis (RA), giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. AVTOZMA, developed by Celltrion, is available in intravenous and subcutaneous formulations with the same dosing regimens as the reference product. This approval represents Celltrion’s seventh biosimilar authorized in the U.S.
The regulatory decision was supported by findings from a phase III clinical trial, led by Gerd Burmester, MD, of the Department of Rheumatology and Clinical Immunology at the Charité University Hospital in Berlin, Germany, and colleagues, assessing the efficacy, safety, pharmacokinetics, and immunogenicity of AVTOZMA in comparison with reference tocilizumab in patients with moderate to severe RA.
The study, presented at the 2024 American College of Rheumatology (ACR) conference and available through ACR Abstracts, enrolled patients randomized to receive either AVTOZMA or the reference biologic. The primary endpoint, mean change from baseline in disease activity score using 28 joints (DAS28)-erythrocyte sedimentation rate at week 24, demonstrated noninferiority of AVTOZMA, with results confirming equivalence to the reference product.
At 1-year, secondary efficacy, pharmacokinetics, safety, and immunogenicity results supported comparability between AVTOZMA and reference tocilizumab, confirming biosimilarity in clinical outcomes. Pharmacokinetics parameters, including area under the concentration-time curve and maximum concentration, demonstrated comparability between AVTOZMA and reference tocilizumab.
It will be available in intravenous concentrations of 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL, and as an subcutaneous injection in a 162 mg/0.9 mL prefilled syringe or autoinjector.
The therapy may increase the risk of serious infections, including tuberculosis, invasive fungal infections such as candidiasis and aspergillosis, and opportunistic infections. Patients should be monitored for signs of infection, including tuberculosis, during and after treatment. Gastrointestinal perforation, hepatic injury, and changes in neutrophil and platelet counts have also been reported.
AVTOZMA is contraindicated in patients with known hypersensitivity to tocilizumab. Its use is not recommended in those with active hepatic disease, and live vaccines should be avoided during treatment.
The availability of both intravenous and subcutaneous formulations provides flexibility and a wider range of treatment options, as noted by Celltrion in a press release.