A review on biosimilar infliximab, CT-P13, in the treatment of inflammatory bowel disease

Immunotherapy. 2018 Feb;10(2):107-117. doi: 10.2217/imt-2017-0107. Epub 2017 Nov 10.

Abstract

The introduction of biological agents has led to significant changes in the treatment of inflammatory bowel disease (IBD). The relatively high price of infliximab (IFX) and the expiration of the patents led to the introduction of biosimilar agents. CT-P13 was the first IFX biosimilar approved in the same indications as the reference product; however, the approval was based on randomized clinical trials conducted in patients with rheumatoid arthritis and ankylosing spondylitis. In the past 2-3 years, new findings from prospective observational studies supported the short-, medium- and long-term clinical efficacy and safety of CT-P13 in patients with IBD. This review summarized the clinical use and efficacy of the first biosimilar IFX, CT-P13, in the treatment of IBD.

Keywords: biosimilar; inflammatory bowel disease; infliximab.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Anti-Inflammatory Agents / pharmacology
  • Anti-Inflammatory Agents / therapeutic use*
  • Antibodies, Monoclonal / pharmacology
  • Antibodies, Monoclonal / therapeutic use*
  • Arthritis, Rheumatoid / drug therapy*
  • Biosimilar Pharmaceuticals / pharmacology
  • Biosimilar Pharmaceuticals / therapeutic use*
  • Clinical Trials as Topic
  • Cost-Benefit Analysis
  • Drug Approval
  • Humans
  • Inflammatory Bowel Diseases / drug therapy*
  • Inflammatory Bowel Diseases / economics
  • Infliximab / pharmacology
  • Infliximab / therapeutic use*
  • Patents as Topic
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors
  • United States

Substances

  • Anti-Inflammatory Agents
  • Antibodies, Monoclonal
  • Biosimilar Pharmaceuticals
  • CT-P13
  • Tumor Necrosis Factor-alpha
  • Infliximab