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World J Gastroenterol. Jan 14, 2017; 23(2): 197-203
Published online Jan 14, 2017. doi: 10.3748/wjg.v23.i2.197
Biosimilars in inflammatory bowel disease: A review of post-marketing experience
Simona Deiana, Tommaso Gabbani, Vito Annese
Simona Deiana, Tommaso Gabbani, Vito Annese, Division of Gastroenterology, AOU Careggi University Hospital, 50139 Firenze, Italy
Author contributions: Gabbani T performed literature research, wrote the first draft and reviewed the article; Deiana S collaborated to literature search and reviewed the article; Annese V designed and coordinated the review, and revised the final draft the manuscript.
Conflict-of-interest statement: No potential conflicts of interest relevant to this article were reported.
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: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Vito Annese, MD, Emergency Department, Division of Gastroenterology, AOU Careggi University Hospital, Largo Brambilla 3, 50139 Firenze, Italy. annesev@aou-careggi.toscana.it
Telephone: +39-55-7946035
Received: August 30, 2016
Peer-review started: August 31, 2016
First decision: September 21, 2016
Revised: October 1, 2016
Accepted: December 21, 2016
Article in press: December 21, 2016
Published online: January 14, 2017
Core Tip

Core tip: Some differences between biosimilars and original biologic drugs exist but they are acceptable if they fall within defined “boundaries of tolerance”: variations in some features of the two molecules are considered important only if clinical relevant. Several real-life clinical data are already available in inflammatory bowel disease patients treated with biosimilars with satisfactory outcomes, but further controlled trials are awaited.