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Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study.
Yu, Kyung-Sang; Kim, Byungwook; Shin, Dongseong; Park, Min Kyu; Hwang, Jun Gi; Kim, Min-Gul; Chung, Hyewon; Ghim, JongLyul; Chung, Jae-Yong; Smolen, Josef S; Burmester, Gerd R; Kim, SungHyun; Bae, YunJu; Jeon, DaBee; Yoo, JaeKyoung; Yang, GoEun; Bae, JiHun; Keystone, Edward.
Afiliación
  • Yu KS; Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
  • Kim B; Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
  • Shin D; Clinical Trial Center, Gachon University Gil Medical Center, Incheon, Republic of Korea.
  • Park MK; Department of Clinical Pharmacology and Therapeutics, Chungbuk National University Hospital, Cheongju, Republic of Korea.
  • Hwang JG; Department of Clinical Pharmacology and Therapeutics, Chungbuk National University Hospital, Cheongju, Republic of Korea.
  • Kim MG; Center for Clinical Pharmacology, Jeonbuk National University College of Medicine and Hospital, Jeonju, Republic of Korea.
  • Chung H; Department of Clinical Pharmacology and Toxicology, Korea University Guro Hospital, Seoul, Republic of Korea.
  • Ghim J; Department of Clinical Pharmacology, Inje University Busan Paik Hospital, Busan, Republic of Korea.
  • Chung JY; Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Gyeonggi-do, Republic of Korea.
  • Smolen JS; Department of Medicine, Medical University of Vienna, Vienna, Austria.
  • Burmester GR; Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
  • Kim S; Medical Science Division, Celltrion, Inc., Incheon, Republic of Korea.
  • Bae Y; Clinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea.
  • Jeon D; Clinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea.
  • Yoo J; Pharmacovigilance Department, Celltrion, Inc., Incheon, Republic of Korea.
  • Yang G; Clinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea.
  • Bae J; Biometrics Center, Celltrion, Inc., Incheon, Republic of Korea.
  • Keystone E; Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Expert Opin Investig Drugs ; 32(5): 429-439, 2023 May.
Article en En | MEDLINE | ID: mdl-37231670
Tocilizumab is a biologic medicine used to treat inflammatory diseases including rheumatoid arthritis. Biosimilars are drugs that are highly similar to an already approved, 'reference' biologic medicine. This means that they do not have any differences from the reference product in factors including structure, biologic function, efficacy, and safety, that might affect how well they work in patients. Biosimilars are often available at a lower cost than reference drugs, so their use can provide patients with better access to expensive treatments. There are no approved biosimilars of tocilizumab so far: CT-P47 is currently in development as a potential tocilizumab biosimilar.In the main part of this study, 289 healthy Asian volunteers were randomly allocated to receive a single injection of either CT-P47 or the reference drug, European Union-approved tocilizumab (EU-tocilizumab). The main aim of the study was to find out whether CT-P47 and EU-tocilizumab were equivalent in terms of pharmacokinetics (drug absorption, distribution, metabolism, and excretion by the body). This is part of a standard process required by regulatory authorities to ensure that biosimilars work as well as their reference drugs. Analysis of blood samples taken over 43 days showed that the pharmacokinetic profiles of CT-P47 and EU-tocilizumab were equivalent, after the volunteers received a single dose of either drug. Safety and immunogenicity (immune responses made to the drug) were also comparable between CT-P47 and EU-tocilizumab. While only healthy Asian adults were included, further research comparing CT-P47 with reference tocilizumab will help to ensure that the findings from the study can be applied to broader populations.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Biosimilares Farmacéuticos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Humans Idioma: En Revista: Expert Opin Investig Drugs Asunto de la revista: TERAPIA POR MEDICAMENTOS Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Biosimilares Farmacéuticos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Humans Idioma: En Revista: Expert Opin Investig Drugs Asunto de la revista: TERAPIA POR MEDICAMENTOS Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido