The scientific and regulatory rationale for indication extrapolation: A case study based on the infliximab biosimilar CT-P13

Walter Reinisch, Edouard Louis, Silvio Danese

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)S17-S26
JournalExpert Review of Gastroenterology and Hepatology
Volume9
DOIs
Publication statusPublished - Sep 28 2015

Fingerprint

Biosimilar Pharmaceuticals
Inflammatory Bowel Diseases
CT-P13
Infliximab

Keywords

  • biosimilar
  • CT-P13
  • extrapolation
  • inflammatory bowel disease
  • infliximab
  • mechanism of action
  • pharmacokinetics

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

@article{806d40d7b61f475ea3bed5ca0cb2b745,
title = "The scientific and regulatory rationale for indication extrapolation: A case study based on the infliximab biosimilar CT-P13",
abstract = "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{\circledR}, Inflectra{\circledR}), 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{\circledR}) 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.",
keywords = "biosimilar, CT-P13, extrapolation, inflammatory bowel disease, infliximab, mechanism of action, pharmacokinetics",
author = "Walter Reinisch and Edouard Louis and Silvio Danese",
year = "2015",
month = "9",
day = "28",
doi = "10.1586/17474124.2015.1091306",
language = "English",
volume = "9",
pages = "S17--S26",
journal = "Expert Review of Gastroenterology and Hepatology",
issn = "1747-4124",
publisher = "Expert Reviews Ltd.",

}

TY - JOUR

T1 - The scientific and regulatory rationale for indication extrapolation

T2 - A case study based on the infliximab biosimilar CT-P13

AU - Reinisch, Walter

AU - Louis, Edouard

AU - Danese, Silvio

PY - 2015/9/28

Y1 - 2015/9/28

N2 - 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.

AB - 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.

KW - biosimilar

KW - CT-P13

KW - extrapolation

KW - inflammatory bowel disease

KW - infliximab

KW - mechanism of action

KW - pharmacokinetics

UR - http://www.scopus.com/inward/record.url?scp=84942307684&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84942307684&partnerID=8YFLogxK

U2 - 10.1586/17474124.2015.1091306

DO - 10.1586/17474124.2015.1091306

M3 - Article

C2 - 26395531

AN - SCOPUS:84942307684

VL - 9

SP - S17-S26

JO - Expert Review of Gastroenterology and Hepatology

JF - Expert Review of Gastroenterology and Hepatology

SN - 1747-4124

ER -