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

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

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Keywords

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

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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