Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 21, 2017; 23(11): 1932-1943
Published online Mar 21, 2017. doi: 10.3748/wjg.v23.i11.1932
Insights on the use of biosimilars in the treatment of inflammatory bowel disease
Michael K Zheng, David Q Shih, Gary C Chen
Michael K Zheng, David Q Shih, F. Widjaja Foundation, Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
Gary C Chen, Comprehensive Digestive Institute of Nevada, Las Vegas, NV 89113, United States
Author contributions: Zheng MK wrote the manuscript; Shih DQ and Chen GC provided critical revisions and final approval.
Conflict-of-interest statement: The authors have declared that no conflict of interest exists.
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: Gary C Chen, MD, Comprehensive Digestive Institute of Nevada, 8530 West Sunset Road, Suite 230, Las Vegas, NV 89113, United States.
Telephone: +1-702-4834483 Fax: +1-702-4834493
Received: November 23, 2016
Peer-review started: November 25, 2016
First decision: December 19, 2016
Revised: January 5, 2017
Accepted: February 17, 2017
Article in press: February 17, 2017
Published online: March 21, 2017

Biologic therapy, such as those that target tumor necrosis factor (TNF) signaling, has proven to be an efficacious method of treatment for patients with inflammatory bowel disease (IBD) with regards to symptom management and mucosal healing. However, the rising prevalence of IBD worldwide and the ever-increasing burden of biologic pharmaceuticals in the health care industry is alarming for insurance companies, clinicians, and patients. The impending patent expiry and the relatively high costs of biologics, particularly anti-TNF agents, have paved the way for biosimilar development for IBD. The United States Food and Drug Administration defines a biosimilar as a biological product that is highly similar to its reference medicinal product, with no clinically meaningful differences in terms of safety, purity, and potency. The hope with biosimilars is that their entry into the market will be able to drive competition between pharmaceutical companies to reduce prices like that of the generic market, and that access to appropriate biologic treatments for IBD patients is increased in the long-term. Yet, there are challenging issues such as indication extrapolation and interchangeability that are still being debated in the field of IBD and must be addressed in future issued guidance. This review will discuss the issues and implications concerning the use of biosimilar therapy for IBD.

Keywords: Biosimilar, Biologic, Inflammatory bowel disease, Ulcerative colitis, Crohn’s disease, Indication extrapolation, Interchangeability

Core tip: The expiration of patent protection for various biologics and increasing health care expenses has paved the way for biosimilars to enter the market. The introduction of biosimilars is expected to produce cost savings in the health care industry as well as provide patients with inflammatory bowel disease with wider access to treatment.