Article (Scientific journals)
The scientific and regulatory rationale for indication extrapolation: A case study based on the infliximab biosimilar CT-P13
Reinisch, W.; Louis, Edouard; Danese, S.
2015In Expert Review of Gastroenterology and Hepatology, 9, p. 17-S26
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Keywords :
CT-P13; Crohn disease; Review; Inflammatory Bowel Diseases; Animals; Anti-Inflammatory Agents; Antibodies, Monoclonal; Biosimilar Pharmaceuticals; Drug Approval; Gastrointestinal Agents; Humans; Infliximab; Therapeutic Equivalency; Tissue Distribution; Treatment Outcome; Tumor Necrosis Factor-alpha
Abstract :
[en] Extrapolation of clinical data from other indications is an important concept in the development of biosimilars. This process depends on strict comparability exercises to establish similarity to the reference medicinal product. However, the extrapolation paradigm has prompted a fierce scientific debate. CT-P13 (Remsima®, Inflectra®), an infliximab biosimilar, is a TNF antagonist used to treat immune-mediated inflammatory diseases. On the basis of totality of similarity data, the EMA approved CT-P13 for all indications held by its reference medicinal product (Remicade®) including inflammatory bowel disease. This article reviews the mechanisms of action of TNF antagonists in immune-mediated inflammatory diseases and illustrates the comparable profiles of CT-P13 and reference medicinal product on which the extrapolation of indications including inflammatory bowel disease is based. © 2015 © Informa UK, Ltd.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Reinisch, W. ;  Division of Gastroenterology, Department of Medicine, McMaster University, Hamilton, ON, Canada
Louis, Edouard   ;  Université de Liège - ULiège > Département des sciences cliniques > Hépato-gastroentérologie
Danese, S. ;  Department of Gastroenterology, IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy
 These authors have contributed equally to this work.
Language :
English
Title :
The scientific and regulatory rationale for indication extrapolation: A case study based on the infliximab biosimilar CT-P13
Publication date :
2015
Journal title :
Expert Review of Gastroenterology and Hepatology
ISSN :
1747-4124
eISSN :
1747-4132
Publisher :
Taylor and Francis Ltd
Volume :
9
Pages :
S17-S26
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 07 December 2017

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