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.

KEYWORDS:

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

Article highlights

• CT-P13 Biosimilar of infliximab RMP is approved by EMA and/or FDA and has demonstrated bioequivalence in all available studies.

• Studies strongly support the clinical equivalence between CT-P13 and infliximab.

• Single switch between infliximab RMP and CT-P13 is a feasible and safe strategy in real-life clinical practice.

• No safety issues have appeared after several years of CT-P13 use.

• A major advantage of biosimilar use is the cost-saving that may increase the access of patients to biologics and/or ease restrictions on dose-intensification for patients in need for such dose-adaptations.

This box summarizes key points contained in the article.

Declaration of interest

S Ben-Horin has received consultancy fees and/or research support from Janssen, Abbvie, Celltrion, Takeda, Pfizer and GSK. The authors have no other relevant affiliations or financial involvement with any organization or entity with financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.