CT-P13: a review on a biosimilar to infliximab in the treatment of inflammatory bowel disease.

Abstract

Introduction: CT-P13 was developed as an infliximab biosimilar in 2013. The primary structure of CT-P13 is identical to that of original infliximab and it has highly similar higher order structure, physiochemical characteristics, and biological properties. To date, data from real-life cohorts and randomized controlled trials show comparable clinical efficacy, safety and immunogenicity of biosimilar CT-P13, and the original reference medicinal Product (RMP). Areas covered: This article reviews the comparability of CT-P13 and the RMP and focuses on the emerging clinical trial and observational cohorts data on efficacy and safety of CT-P13 in inflammatory bowel disease (IBD) patients. The development of a subcutaneous formulation of Infliximab CT-P13 is also addressed. Expert opinion: There is a plethora of evidence to show CT-P13 is non-inferior to infliximab RMP in IBD and that a switch from RMP to this biosimilar is feasible and safe. However, interchangeability and multiple switches can still not be endorsed for introduction into clinical practice.

• Authors: Ahmad Albshesh, Shomron Ben-Horin
• Journal: Expert opinion on biological therapy (Expert Opin Biol Ther) Vol. 19 Issue 10 Pg. 971-978 (10 2019) ISSN: 1744-7682 [Electronic] England
• PMID: 31401899 (Publication Type: Journal Article, Review)

Chemical References

• Antibodies, Monoclonal
• CT-P13

Topics

• Antibodies, Monoclonal (administration & dosage)
• Humans
• Inflammatory Bowel Diseases (drug therapy)
• Randomized Controlled Trials as Topic
• Treatment Outcome