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CT-P13: design, development, and place in therapy

Authors Gabbani T, Deiana S, Annese V

Received 20 December 2016

Accepted for publication 11 April 2017

Published 6 June 2017 Volume 2017:11 Pages 1653—1661

DOI https://doi.org/10.2147/DDDT.S109852

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Colin Mak

Peer reviewer comments 2

Editor who approved publication: Prof. Dr. Frank Boeckler

Tommaso Gabbani,1 Simona Deiana,2 Vito Annese3

1Gastroenterology Unit, Morgagni-Pierantoni Hospital, AUSL Romagna, Forlì, 2Division of Gastroenterology, AOU Careggi University Hospital, Florence, Italy; 3Gastroenterology Department, Valiant Clinic, Dubai, UAE

Abstract: The introduction of biological agents has revolutionized the management of many life-threatening and debilitating immune-mediated diseases. Because of the high cost of biological drugs and their patent expiration, the market has opened to biosimilar agents, copy versions of the originators, which can lead to reduced health care expenditure and increase treatment access worldwide. CT-P13 is the first biosimilar of infliximab (IFX) and has been approved for the same indications as its originator drug. It obtained regulatory approval by the European Medicines Agency in September 2013 and by the US Food and Drug Administration in April 2016. The Phase I and Phase III clinical trials conducted in ankylosing spondylitis and rheumatoid arthritis have demonstrated pharmacokinetic and efficacy equivalence with comparable safety and immunogenicity to IFX. For these reasons, the use of CT-P13 has been extrapolated also to inflammatory bowel disease. There have been some initial concerns regarding the use of CT-P13 in inflammatory bowel disease patients, because of the lack of randomized controlled trials. However, emerging real-world data have further confirmed the comparability between CT-P13 and its reference product in terms of efficacy, safety, and immunogenicity, in patients naïve to the anti-tumor necrosis factor alpha agents and after switching from IFX, and will be summarized in this review.

Keywords: CT-P13, infliximab, biosimilar, biologic therapy, Crohn’s disease, ulcerative colitis

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Development, safety, and efficacy of biosimilar adalimumab: the data so far

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Biosimilars 2016, 6:1-7

Published Date: 29 January 2016