Celltrion Reveals Promising Phase III Study Results for CT-P47 Biosimilar at EULAR 2024

Celltrion Reveals Positive Phase III Data for CT-P47 Biosimilar at EULAR 2024

Celltrion presented encouraging Phase III data for CT-P47, a biosimilar candidate referencing RoActemra® in patients with moderate to severe rheumatoid arthritis (RA) at the Annual European Congress of Rheumatology (EULAR) 2024. The comparative trial demonstrated equivalent efficacy and a comparable safety and immunogenicity profile between CT-P47 and the reference product, tocilizumab.

In the study, 471 patients with moderate to severe RA received either CT-P47 or reference tocilizumab every 4 weeks for the first 20 weeks. The primary endpoint, disease activity score 28, showed comparable improvement between the two groups at weeks 12 and 24. The study also found similar pharmacokinetics, safety, and immunogenicity profiles between CT-P47 and tocilizumab.

Dr. Josef S. Smolen, Emeritus Professor of Medicine at the Medical University of Vienna, Austria, stated, “Biosimilars like CT-P47 provide an opportunity to address unmet medical needs by expanding access to high-quality biologic medicines.”

Additionally, a phase I/III study compared the pharmacokinetic (PK) similarity between CT-P47 autoinjector (AI) and prefilled syringe (JP). The study demonstrated PK similarity and greater ease of use with the CT-P47 AI in patients with RA compared to the prefilled syringe.

Taehun Ha, Vice President and Director of Celltrion’s European Division, emphasized, “The availability of tocilizumab biosimilars like CT-P47 offers an opportunity to reduce treatment costs, improve patient access, and enhance treatment adherence.”

CT-P47, containing tocilizumab, is a humanized recombinant monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. It was submitted for regulatory approval to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in January and February 2024, respectively.

Rheumatoid arthritis (RA) is a chronic inflammatory disease affecting approximately 1% of the world’s population. While there is no cure, early treatment with therapies like CT-P47 can help manage symptoms and reduce joint damage.

Celltrion, headquartered in Incheon, South Korea, is a leading biopharmaceutical company specializing in innovative therapies, including monoclonal antibody biosimilars and novel treatments, to improve global healthcare accessibility.

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