Biosimilar infliximab: An expert view

A. Genazzani, G. Altomare, N. Balato, F. Cusano, O. Depità, F. Loconsole, G. Micali, S. Piaserico, G. Girolomoni

Research output: Contribution to journalArticle

Abstract

CT-P13, a biosimilar of infliximab, was the first biosimilar monoclonal antibody to be approved in both the European Union and Korea. As a monoclonal antibody, CT-P13 is a large molecule with a high molecular weight, and as such it differs from other biosimilars currently in the market. The comparability exercise for CT-P13, therefore, requires special consideration, as it was the first demonstration of biosimilarity between a biosimilar monoclonal antibody and its originator. This paper summarizes current regulations on the approval of biosimilars, describes the evidence leading to the approval of CT-P13, and discusses the potential role of this molecule in the Italian scenario on the basis of the view of a group of experts.

Original languageEnglish
Pages (from-to)449-459
Number of pages11
JournalGiornale Italiano di Dermatologia e Venereologia
Volume150
Issue number4
Publication statusPublished - Aug 1 2015

Keywords

  • Ankylosing
  • Arthritis
  • Biosimilar pharmaceuticals
  • Dermatology
  • Infliximab
  • Rheumatoid
  • Spondylitis

ASJC Scopus subject areas

  • Dermatology

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  • Cite this

    Genazzani, A., Altomare, G., Balato, N., Cusano, F., Depità, O., Loconsole, F., Micali, G., Piaserico, S., & Girolomoni, G. (2015). Biosimilar infliximab: An expert view. Giornale Italiano di Dermatologia e Venereologia, 150(4), 449-459.