Opinion Review
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. May 16, 2022; 10(14): 4327-4333
Published online May 16, 2022. doi: 10.12998/wjcc.v10.i14.4327
Emerging role of biosimilars in the clinical care of inflammatory bowel disease patients
Hala Najeeb, Farah Yasmin, Salim Surani
Hala Najeeb, Farah Yasmin, Department of Internal Medicine, Dow University of Health Sciences, Karachi 74200, Pakistan
Salim Surani, Department of Medicine, Texas A&M University, College Station, TX 77843, United States
Salim Surani, Department of Anesthesiology, Mayo Clinic, Rochester, MN 55905, United States
Author contributions: Najeeb H and Yasmin F contributed to the conception of the study, primary drafting of the work, final approval, and agreeing to the accuracy of the work; Surani S contributed to the supervision, critical revision of the work, final approval, and review of the accuracy of the work.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Salim Surani, FACP, FCCP, MD, MSc, Doctor, Professor, Department of Medicine, Texas A&M University, 400 Bizzell St, College Station, TX 77843, United States. srsurani@hotmail.com
Received: October 27, 2021
Peer-review started: October 27, 2021
First decision: December 12, 2021
Revised: January 20, 2022
Accepted: March 27, 2022
Article in press: March 27, 2022
Published online: May 16, 2022
Processing time: 197 Days and 16.6 Hours
Abstract

The increasing incidence of inflammatory bowel disease (IBD) globally has redirected the healthcare system's focus towards safe and affordable pharmacological interventions. The inception of anti-tumor necrosis factor-α (TNF-α) had resulted in a trend shift from surgical interventions. However, as the patents of approved anti-TNF-α drugs expire, biological copies of the many approved products are in the pipeline. The most commonly used biosimilar for IBD has been infliximab, followed by Adalimumab biosimilars which have been approved in major countries across the world. Although biosimilars are approved on the basis of similarity of their reference product, the lack of real-world evidence of its safety in ulcerative colitis and Crohn’s disease patients has contributed to physicians’ hesitancy. However, biosimilars are expected to reduce treatment costs and provide economic benefits.

Keywords: Inflammatory bowel disease; Biosimilars; Anti-tumor necrosis factor; Infliximab; Adalimumab; Ulcerative colitis; Chrons disease

Core Tip: There is limited evidence on the safety and use of biosimilars other than Infliximab. This review explores the role of biosimilars in an era of anti-tumor necrosis factor-α drug as a treatment option for inflammatory bowel disease. The approval of biosimilars by the Food and Drug Administration or European Medicines Agency based on their similarity and functionality to the reference product has raised concerns regarding its efficacy. Many remain hesitant in recommending biosimilars as a viable treatment option, despite its promise of reducing long-term costs. This originates from the lack of clinical trials of biosimilars. Although no serious adverse events have been reported with biosimilars, conclusions cannot be drawn without sufficient empirical evidence.