Celltrion presents positive phase III results for CT-P47 biosimilar at EULAR 2024

Celltrion, a biopharmaceutical company based in Incheon, South Korea, announced promising results from a Phase III clinical trial for their biosimilar candidate, CT-P47, which references RoActemra®. The findings were presented at the Annual European Congress of Rheumatology (EULAR) 2024. The study focused on patients with moderate-to-severe rheumatoid arthritis (RA) and aimed to compare the efficacy, safety, and immunogenicity of CT-P47 with the reference drug, tocilizumab.

In the study, 471 patients with moderate to severe RA were randomly assigned to receive either CT-P47 or reference tocilizumab. The treatment was administered every four weeks at a dose of 8 mg/kg for the initial 20 weeks. At week 24, those on tocilizumab were re-randomized to either continue with the reference drug or switch to CT-P47 until week 48. The primary endpoint measured was the improvement in the disease activity score 28 (DAS28) based on erythrocyte sedimentation rate (ESR) at weeks 12 and 24.

Results showed that the differences in DAS28 (ESR) between the two groups were minor, with estimated differences of -0.01 at week 12 and -0.1 at week 24. These differences fell within the pre-defined equivalence margins, confirming that CT-P47 and tocilizumab have comparable efficacy. Moreover, both groups displayed similar mean serum concentrations up to week 32 and had comparable safety profiles, including the incidence of treatment-emergent adverse events and anti-drug antibody positivity.

Dr. Josef S. Smolen, Emeritus Professor of Medicine at the Medical University of Vienna, stated that the positive results reinforce the biosimilarity of CT-P47 to tocilizumab, offering potential for switching between the two treatments. This could expand access to high-quality biologic medicines and address unmet medical needs in the RA patient population.

Additionally, a Phase I/III study examined the pharmacokinetic (PK) similarity between the CT-P47 autoinjector (AI) and the pre-filled syringe (PFS). The study included healthy subjects and RA patients to assess usability and safety. Results indicated that the PK profiles of the AI and PFS were similar, and the AI had higher usability among RA patients. Moreover, no new safety concerns were identified, and the AI was well tolerated.

Taehun Ha, Vice President and Head of Europe Division at Celltrion, emphasized that the AI could improve treatment compliance by offering an alternative to the pre-filled syringe. The availability of biosimilars like CT-P47 could reduce treatment costs, enhance healthcare budget sustainability, and improve patient access to essential biologic therapies. Celltrion remains committed to expanding its portfolio of biosimilars for immunology, aiming to enhance the quality of life for patients and the sustainability of healthcare systems.

Rheumatoid arthritis (RA) is a chronic inflammatory disorder that affects approximately 1% of the global population. It causes pain, swelling, and stiffness in the joints due to immune system dysfunction. While the exact cause of RA is unknown, early treatment with disease-modifying anti-rheumatic drugs (DMARDs) and biological therapies can mitigate joint damage and reduce the impact of the condition.

CT-P47, containing tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on the positive global Phase III clinical trial data, Celltrion has filed for regulatory approval of CT-P47 with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) earlier in 2024.

Celltrion, known for its innovative therapeutics, continues to develop and market monoclonal antibody biosimilars and other novel treatments, aiming to improve accessibility and affordability of essential medicines worldwide.