Biosimilars in Inflammatory Bowel Disease

Over the past 2 decades, biological therapy with monoclonal antibodies targeting tumor necrosis factor-α has become a cornerstone of treatment of patients with inflammatory bowel disease. Although clinically effective, the biological therapies remain expensive, and their availability and utilization...

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Bibliographic Details
Published inThe American journal of gastroenterology Vol. 116; no. 1; pp. 45 - 56
Main Authors Buchner, Anna M, Schneider, Yecheskel, Lichtenstein, Gary R
Format Journal Article
LanguageEnglish
Published United States Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins 01.01.2021
Subjects
Adalimumab - economics
Adalimumab - therapeutic use
Autoimmune diseases
Biological products
Biosimilar Pharmaceuticals - economics
Biosimilar Pharmaceuticals - therapeutic use
Drug Costs
Drug Substitution
FDA approval
Gastroenterology
Health Expenditures
Health Services Accessibility
Humans
Inflammatory bowel disease
Inflammatory Bowel Diseases - drug therapy
Infliximab - economics
Infliximab - therapeutic use
Pharmacokinetics
Regulatory approval
Tumor Necrosis Factor Inhibitors - therapeutic use
Tumor necrosis factor-TNF
United States > US
Europe
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Summary:Over the past 2 decades, biological therapy with monoclonal antibodies targeting tumor necrosis factor-α has become a cornerstone of treatment of patients with inflammatory bowel disease. Although clinically effective, the biological therapies remain expensive, and their availability and utilization have been at times limited due to their high costs. Biosimilars are biological products similar to but not identical to the original biological agent or "reference biologic," also called "originator biologic." It is hoped that the use of biosimilars might enable these agents to become more available and, thus, decrease further expenditures related to the use of the original reference agents such as infliximab and adalimumab. In this study, we review the currently available evidence and shortcomings of these data supporting the use of biosimilars for the treatment of patients with inflammatory bowel disease, including their efficacy and safety as related to initiating therapy with biosimilar agents or switching between reference and biosimilar biologic agents.
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ISSN:0002-9270
1572-0241
DOI:10.14309/ajg.0000000000000844