78-Week results from Phase III randomized controlled trial (RCT) including switching data from reference denosumab to CT-P41 (biosimilar candidate of denosumab) demonstrate comparable efficacy and safety results; Results support the therapeutic equivalence of CT-P41 and reference denosumab in treating postmenopausal women with osteoporosis (PMO)[1]
Data from the Phase III RCT showed comparable and sustained efficacy,safety and immunogenicity profile to the reference tocilizumab in patients with active moderate-to-severe rheumatoid arthritis (RA) over 1-year after single transition from Week 24[2]
JERSEY CITY,N.J.,Nov. 19,2024 -- Celltrion today presented additional data from a Phase III randomized controlled trial (RCT)for CT-P41,a biosimilar candidate referencing PROLIA®/XGEVA® (denosumab) in postmenopausal women with osteoporosis (PMO) and a Phase III RCTfor CT-P47,a biosimilar candidate referencing ACTEMRA® (tocilizumab) in patients with moderate-to-severe active rheumatoid arthritis (RA) at the American College of Rheumatology (ACR) Convergence 2024 in Washington,D.C.
The additional efficacy and safety results from Week 52 to Week 78 including switching data from reference denosumab to the CT-P41 (Treatment Period [TP] 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.[1]
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.[3]Despite the high ADA incidence compared to the reference denosumab historical studies,[4] it can be suggested that ADA to CT-P41 and referencedenosumab 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,PharmD,MBA,Head of Medical Affairs at CelltrionUSA. "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 1-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.[2]
"Biosimilars offer cost savings and health gains for our patients and play an important role in treating rheumatic diseases," said Prof. Gerd-Rüdiger Burmester,MD,Professor of Medicine and Rheumatology,Senior Professor in the Department of Rheumatology and Clinical Immunology at Charité - Universitätsmedizin Berlin,Germany. "The RCT data of CT-P47 presented at ACR further establish the comparable safety and efficacy of biosimilars to their reference products."
About Celltrion
Celltrion is a leading biopharmaceutical company based in Incheon,South Korea that specializes in researching,developing,manufacturing,marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion currently has five biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb),TRUXIMA® (rituximab-abbs),HERZUMA® (trastuzumab-pkrb),VEGZELMA® (bevacizumab-adcd) and YUFLYMA®(adalimumab-aaty) as well as a novel biologic ZYMFENTRA®.
About Celltrion USA
Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey,Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology,supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information,please visit: www.celltrionusa.com.
About CT-P41 (biosimilar candidate of denosumab)
CT-P41 is a proposed biosimilar of reference denosumab,a fully human monoclonal antibody that binds the cytokine receptor activator of NF-κb 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 U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in November 2023 and March 2024,respectively.
About CT-P47 (biosimilar candidate of tocilizumab)
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,pharmacokinetics (PK),and immunogenicity of CT-P47 compared to reference tocilizumab,CT-P47 was filed for regulatory approval with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in January and February 2024,respectively.
FORWARD-LOOKING STATEMENT
Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc./Celltrion USA that may constitute forward-looking statements,under pertinent securities laws.
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Such Risks and uncertainties may include,among other things,uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain,research and development,and the possibility of unfavorable new clinical data and further analyses of existing clinical data as it relates to Celltrion products; intellectual property and/or litigation/settlement implications; decisions by the FDA impacting labeling,manufacturing processes,promotion,and/or other matters that could affect the availability or commercial potential of Celltrion products; and uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to competitive products; and competitive developments. A further description of risks and uncertainties can be found in Celltrion's Annual Report.
Although forward-looking statements are based upon what management of Celltrion Inc./Celltrion USA believes are reasonable assumptions,there can be no assurance that forward-looking statements will prove to be accurate,as actual results and future events could differ materially from those anticipated in such statements. Celltrion Inc./Celltrion USA undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
Trademarks
PROLIA® and XGEVA® are registered trademarks of Amgen Inc.
ACTEMRA® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp.,a member of the Roche Group.
References
[1] Jean-Yves Reginster et al.,Efficacy and Safety Results of CT-P41 (Proposed Denosumab Biosimilar) Compared to Reference Denosumab in Postmenopausal Women with Osteoporosis: 78-Week Results from Phase 3 Randomized Controlled Trial. Oral Presentation (abstract no. 2563). Presented at ACR 2024
[2] Gerd Burmester 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. Poster Presentation (abstract no. 0502). Presented at ACR 2024.
[3] Jean-Yves Reginster et al.,Impact of Immunogenicity on Clinical Outcomes in Postmenopausal Women with Osteoporosis: Results from a Randomized Controlled Phase 3 Study to Compare CT-P41 (Proposed Denosumab Biosimilar) and Reference Denosumab. Poster Presentation (abstract no. 2144). Presented at ACR 2024.
[4] Denosumab U.S. Prescribing Information (2024)
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