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

Ahmad Albshesh, Shomron Ben-Horin*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

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.

Original languageEnglish
Pages (from-to)971-978
Number of pages8
JournalExpert Opinion on Biological Therapy
Volume19
Issue number10
DOIs
StatePublished - 3 Oct 2019
Externally publishedYes

Funding

FundersFunder number
Pfizer
Takeda Pharmaceutical Company
GlaxoSmithKline Australia

    Keywords

    • Anti TNF
    • CT-P13
    • Crohn’s disease
    • biosimilar
    • drug monitoring
    • original infliximab
    • ulcerative colitis

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