Nguyen CD, Dang LM. Biosimilars in inflammatory bowel disease: Beyond evidence, toward trust and implementation. World J Gastroenterol 2026; 32(28): 119462 [DOI: 10.3748/wjg.119462]
Corresponding Author of This Article
Luan Minh Dang, MD, Lecturer, Department of Gastroenterology, University Medical Center, No. 215 Hong Bang Street, Cho Lon Ward, Ho Chi Minh City 700000, Viet Nam. luan.dm@umc.edu.vn
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
review-article
Open-Access Policy of This Article
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: http://creativecommons.org/licenses/by-nc/4.0/
Luan Minh Dang, Department of Internal Medicine and Gastro-Hepato Integrated Research Team (GHIRT-002.TCM2025), School of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City 700000, Viet Nam
Author contributions: Dang LM conceived the review, performed the primary drafting, and developed the proposed clinical framework; Nguyen CD contributed to conceptualization, critical revision, and manuscript editing; both authors interpreted the literature, approved the final manuscript, and agree to be accountable for all aspects of the work.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Corresponding author: Luan Minh Dang, MD, Lecturer, Department of Gastroenterology, University Medical Center, No. 215 Hong Bang Street, Cho Lon Ward, Ho Chi Minh City 700000, Viet Nam. luan.dm@umc.edu.vn
Received: January 28, 2026 Revised: February 15, 2026 Accepted: April 8, 2026 Published online: July 28, 2026 Processing time: 165 Days and 14.2 Hours
Abstract
The growing burden of inflammatory bowel disease (IBD) has increased pressure on healthcare systems to deliver effective biologic therapy at sustainable cost. Biosimilars offer an important opportunity to expand access to advanced treatment, yet their uptake in IBD remains inconsistent despite substantial evidence supporting comparable efficacy, safety, and immunogenicity. In this opinion review, we examine the current evidence for biosimilar use in IBD, including biologic-naive initiation, single switching, multiple switching, and emerging reverse-switch data. We also analyze the key controversies that continue to impede adoption, particularly immunogenicity, indication extrapolation, non-medical switching, and switch-back decisions. Beyond evidence-level debates, we examine the multi-level barriers that shape biosimilar implementation in practice, including the nocebo effect, physician hesitation, and system-level implementation constraints. We further propose a pragmatic 5-step framework to support structured biosimilar initiation or switching in routine IBD care. Finally, we consider the distinctive challenges of biosimilar implementation in resource-limited settings and introduce the concept of a “nocebo-prone environment” as a proposed explanatory lens for understanding barriers to equitable biosimilar integration.
Core Tip: Biosimilars in inflammatory bowel disease have moved beyond a narrow question of pharmacological equivalence. Although current evidence supports their efficacy, safety, and use across multiple clinical scenarios, adoption remains limited by nocebo-related discontinuation, physician hesitation, and system-level implementation barriers. This opinion review synthesizes current evidence, examines persistent controversies, and proposes a pragmatic 5-step framework for biosimilar initiation or switching in routine care. It also highlights the special challenges of resource-limited settings and introduces the concept of a “nocebo-prone environment” as a practical lens for understanding barriers to equitable biosimilar integration.
