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WASHINGTON — Celltrion presented additional data from a Phase III randomized controlled trial (RCT) for CT-P41, a biosimilar candidate referencing Amgen’s Prolia/Xgeva (denosumab) in postmenopausal women with osteoporosis (PMO) and a Phase III RCT for CT-P47, a biosimilar candidate referencing Genentech’s Actemra (tocilizumab) in patients with moderate-to-severe active rheumatoid arthritis (RA) at the American College of Rheumatology (ACR) Convergence 2024.
The additional efficacy and safety results from Week 52 to Week 78 including switching data from reference denosumab to the CT-P41 (Treatment Period II) showed comparable and sustained efficacy results to reference denosumab in treating women with PMO after the single transition from reference denosumab to CT-P41. CT-P41 was well tolerated with a safety profile comparable to reference denosumab, and no notable safety issue was identified following the single transition compared with maintenance groups up to Week 78. The results further support the biosimilarity between CT-P41 and reference denosumab in treating women with PMO.
In addition, post-hoc impact analysis using data from the Phase III RCT was conducted to determine any correlation between immunogenicity and clinical outcomes in PMO between the treatment groups. According to the results, the impact of anti-drug antibody (ADA) on pharmacokinetics (PK), efficacy and safety and the treatment emergent adverse events (TEAE) incidences were comparable between the treatment groups in the ADA status groups. Despite the high ADA incidence compared to the reference denosumab historical studies, it can be suggested that ADA to CT-P41 and reference denosumab has no clinical impact considering the high sensitivity and specificity of the assay and further evaluation of immunogenicity impact.
“We are excited to announce the additional evidence from the RCT that further supports the biosimilarity between CT-P41 and reference denosumab in treating PMO,” said Hetal Patel, head of medical affairs at Celltrion USA. “These results further underline the capabilities of our dedicated biosimilar platform and anticipated diversification of our portfolio.”
Results of the single transition from the reference tocilizumab to CT-P47 from a Phase III RCT were also presented at the ACR. The one-year results showed that CT-P47 had comparable and sustained efficacy, safety and immunogenicity profiles in patients with active moderate-to-severe rheumatoid arthritis (RA) compared to the reference tocilizumab even after switching. These data further support biosimilarity of CT-P47.
“Biosimilars offer cost savings and health gains for our patients and play an important role in treating rheumatic diseases,” said Dr. Gerd-Rüdiger Burmester, professor of medicine and rheumatology, and senior professor in the Department of Rheumatology and Clinical Immunology at Charité – Universitätsmedizin in Berlin. “The RCT data of CT-P47 presented at ACR further establish the comparable safety and efficacy of biosimilars to their reference products.”
Incheon, South Korea-based Celltrion has five biosimilars approved by the Food and Drug Administration: Inflectra (infliximab-dyyb), Truxima (rituximab-abbs), Herzuma (trastuzumab-pkrb), Vegzelma (bevacizumab-adcd) and Yuflyma(adalimumab-aaty) as well as novel biologic Zymfentra.
CT-P41 is a fully human monoclonal antibody that binds the cytokine receptor activator of NF-kb ligand (RANKL). Based on data from the Phase III clinical trial designed to evaluate the efficacy, safety and immunogenicity of CT-P41 compared to the reference denosumab, CT-P41 was filed for regulatory approval with the FDA and European Medicines Agency (EMA) in November 2023 and March, respectively.
CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial designed to evaluate the efficacy, PK, safety and immunogenicity of CT-P47 compared to reference tocilizumab, CT-P47 was filed for regulatory approval with the FDA and EMA in January and February, respectively.
