Tocilizumab Biosimilar Approved for Rheumatological Diseases, COVID-19

Gerd R. Burmester, MD

Credit: Universitätsmedizin Berlin

The FDA has approved Celltrion’s tocilizumab-anoh biosimilar (CT-P47) under the name Avtozmain both an intravenous (IV) and subcutaneous (SC) formulation for treating rheumatological diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), and systemic juvenile idiopathic arthritis (sJIA), as well as coronavirus disease (COVID-19).¹

"Introducing both IV and SC formulations of AVTOZMA provides flexibility and a wider range of treatment options," Thomas Nusbickel, Chief Commercial Officer at Celltrion USA said in a statement.¹ "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 healthcare providers. Our goal is to provide safe and effective alternatives and ensure appropriate access so plan sponsors can address unique population needs."

Tocilizumab-anoh will be available in its IV formulation as 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) and in its SC formulation in 162 mg/0.9 mL in a single-dose prefilled syringe or single-dose autoinjector.

The approval was based on data from a phase 3 study demonstrating biosimilarity between AVTOZMA and reference tocilizumab in patients with moderate to severe active RA. The study’s primary endpoint, change from baseline in disease activity score using 28 joints (DAS28)-ESR, was met at Week 24. The final 1-year results also supported comparability in secondary efficacy, pharmacokinetic (PK), safety and immunogenicity between tocilizumab-anohand reference tocilizumab. 

These data were presented by Gerd R. Burmester, MD, Professor of Medicine, Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, and Humboldt University and Free University, at the American College of Rheumatology (ACR) Convergence 2024, held in November in Washington, DC.²

Of the 444 participants re-randomized, 412 (92.8%) completed the study (CT-P47 maintenance, 210; ref-tocilizumab maintenance, 100; switch, 102). The investigators found that the mean change from baseline of DAS28 was not affected by the transition from ref-tocilizumab to CT-P47 at Week 24. Comparable improvements in clinical activity were observed up to Week 52 as measured by American College of Rheumatology (ACR)20/50/70 responses and remissions by clinical disease activity index (CDAI), simplified DA (SDAI), and Boolean-definition (v2.0). By Boolean definition, ACR/European Alliance of Associations for Rheumatology (EULAR) remission was met at week 24 by 67 (29.8%), 27 (24.8%), and 30 (27.3%) of the CT-P47 maintenance, ref-tocilizumab, and switch group, respectively; and at week 52 by 89 (39.6%), 46 (42.2%), and 56 (50.9%) of the groups, respectively. The mean pre-dose serum concentration was similar among the groups up to Week 52 (CT-P47 Maintenance,16.73 μg/mL; ref-tocilizumab Maintenance; 17.41 μg/m; switch, 17.32 μg/mL).²

"Biosimilars offer cost savings and health gains for our patients and play an important role in treating rheumatic diseases," Burmester said in a statement.³ "The RCT data of CT-P47 presented at ACR further establish the comparable safety and efficacy of biosimilars to their reference products.

REFERENCES
1. U.S. FDA approves Celltrion's AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA®. News release. Celltrion. January 31, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/3668

2. Burmester G, Trefler J, Racewicz A, et al. Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study. Presented at: ACR Convergence 2024; November 14-19; Washington, DC. Abstract 0502

3. Celltrion presents additional data from phase III randomized controlled trials to further support biosimilarity for CT-41 (biosimilar candidate of denosumab) and CT-P47 (biosimilar candidate of tocilizumab) at American College of Rheumatology (ACR) Convergence 2024. News release. Celltrion. November 18, 2024.