Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Sep 21, 2018; 24(35): 4021-4027
Published online Sep 21, 2018. doi: 10.3748/wjg.v24.i35.4021
Biosimilars in paediatric inflammatory bowel disease
Joanna Sieczkowska-Golub, Dorota Jarzebicka, Grzegorz Oracz, Jaroslaw Kierkus
Joanna Sieczkowska-Golub, Dorota Jarzebicka, Grzegorz Oracz, Jaroslaw Kierkus, The Department of Gastroenterology, Hepatology, Feeding Disorders and Paediatrics, The Children’s Memorial Health Institute, Warsaw 04-730, Poland
Author contributions: All authors contributed equally to this paper including concept and design, literature review and analysis, preparation of the draft manuscript, critical revision and editing, and approval of the final version.
Conflict-of-interest statement: Kierkus J has received speaker fees from Egis and AbbVie.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Correspondence to: Jaroslaw Kierkus, MD, PhD, Full Professor, The Department of Gastroenterology, Hepatology, Feeding Disorders and Paediatrics, The Children’s Memorial Health Institute, Aleja Dzieci Polskich 20, Warsaw 04-730, Poland.
Telephone: +48-22-8157392 Fax: +48-22-8157382
Received: June 7, 2018
Peer-review started: June 7, 2018
First decision: July 12, 2018
Revised: August 14, 2018
Accepted: August 24, 2018
Article in press: August 24, 2018
Published online: September 21, 2018

The introduction of biological treatments has changed disease outcomes for patients with inflammatory bowel disease. Biologicals have high efficacy, and can induce and maintain remission after failed responses to conventional immunosuppressive and/or steroid therapy. The increasing occurrence of severe disease at diagnosis has resulted in infliximab being more often introduced as the first-line treatment in a “top-down” approach. Besides their favourable efficacy and safety profile, biologicals have one significant disadvantage, which is their high cost. This results in many patients stopping therapy prematurely, with the maintenance phase being too short. This often leads to disease exacerbation shortly after treatment cessation. Every newly started course of biological therapy can induce production of anti-drug antibodies, which can result in treatment failure and possible allergic/anaphylactic reactions. The introduction of biological biosimilars was intended to greatly reduce therapy costs thus increasing the availability of these agents to more patients. It was also anticipated that biosimilars would prevent premature termination of therapy. Analyses of paediatric data suggest that biosimilar infliximabs are equally effective as the reference infliximab. Safety patterns also seem to be similar. Paediatric experience places cost-therapy reductions at around 10%-30%.

Keywords: Biosimilars, Paediatric inflammatory bowel disease, Infliximab, Biological treatment, Crohn’s disease, Ulcerative colitis

Core tip: Data on the use of biosimilars among paediatric patients are limited. Nevertheless, several original papers support adult findings that biosimilars are as effective and safe as the reference infliximab in this population.