{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,14]],"date-time":"2026-02-14T20:57:33Z","timestamp":1771102653880,"version":"3.50.1"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2021,2,15]],"date-time":"2021-02-15T00:00:00Z","timestamp":1613347200000},"content-version":"vor","delay-in-days":45,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Biosimilars are highly similar but nonidentical biologic agents with no differences in clinical efficacy and safety when compared to bio-originator products. Considering the long-term costs of managing inflammatory bowel disease (IBD), biosimilars, through economic competition, provide an opportunity for cost savings to payors, may increase access to IBD medications, and could decrease health care spending in the long run. Studies investigating the use of biosimilars in IBD have shown a comparable clinical efficacy and safety profile compared to originator products. Moreover, studies have also suggested that solitary switches between bio-originators and biosimilars are acceptable and do not lead to worsening disease burden or increased immunogenicity or safety concerns. Despite available data and proposed benefits of biosimilars, skepticism about the widespread adoption of biosimilars throughout the United States continues to be present and creates many barriers. Herein, we detail the real-world, nonmedical switching experiences of 2 IBD centers in the United States and review best practices, which can be used as a potential roadmap for successful biosimilar adoption in other institutions.<\/jats:p>","DOI":"10.1093\/crocol\/otaa093","type":"journal-article","created":{"date-parts":[[2020,11,20]],"date-time":"2020-11-20T20:43:42Z","timestamp":1605905022000},"source":"Crossref","is-referenced-by-count":9,"title":["Switching from Infliximab to Biosimilar in Inflammatory Bowel Disease: A Review of Existing Literature and Best Practices"],"prefix":"10.1093","volume":"3","author":[{"given":"Shubha","family":"Bhat","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Crohn\u2019s and Colitis Program, Boston Medical Center , Boston, Massachusetts, USA"},{"name":"Department of Gastroenterology, Crohn\u2019s and Colitis Program, Boston Medical Center , Boston, Massachusetts, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Taha","family":"Qazi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology & Nutrition, Digestive Diseases Institutes, Cleveland Clinic , Cleveland, Ohio, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2021,2,15]]},"reference":[{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"2462","DOI":"10.1056\/NEJMoa050516","article-title":"Infliximab for induction and maintenance therapy for ulcerative colitis","volume":"353","author":"Rutgeerts","year":"2005","journal-title":"N Engl J Med."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"1541","DOI":"10.1016\/S0140-6736(02)08512-4","article-title":"Maintenance infliximab for Crohn\u2019s disease: the ACCENT I randomised trial","volume":"359","author":"Hanauer","year":"2002","journal-title":"Lancet."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"481","DOI":"10.1038\/ajg.2018.27","article-title":"ACG clinical guideline: management of Crohn\u2019s disease in adults","volume":"113","author":"Lichtenstein","year":"2018","journal-title":"Am J Gastroenterol."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"384","DOI":"10.14309\/ajg.0000000000000152","article-title":"ACG clinical guideline: ulcerative colitis in adults","volume":"114","author":"Rubin","year":"2019","journal-title":"Am J Gastroenterol."},{"key":"2023030920550655000_","first-page":"3","article-title":"Biosimilar cost savings in the United States: initial experience and future potential","volume":"7","author":"Mulcahy","year":"2018","journal-title":"Rand Health Q."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1093\/ibd\/izz104","article-title":"The cost of inflammatory bowel disease: an initiative from the Crohn\u2019s & Colitis Foundation","volume":"26","author":"Park","year":"2020","journal-title":"Inflamm Bowel Dis."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"72","DOI":"10.1136\/gutjnl-2012-303376","article-title":"Healthcare costs of inflammatory bowel disease have shifted from hospitalisation and surgery towards anti-TNF\u03b1 therapy: results from the COIN study","volume":"63","author":"van der Valk","year":"2014","journal-title":"Gut."},{"key":"2023030920550655000_","first-page":"410","article-title":"Process and clinical outcomes of a biosimilar adoption program with infliximab-dyyb","volume":"26","author":"Bhat","year":"2020","journal-title":"J Manag Care Spec Pharm."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"2304","DOI":"10.1016\/S0140-6736(17)30068-5","article-title":"Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial","volume":"389","author":"J\u00f8rgensen","year":"2017","journal-title":"Lancet."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"1523","DOI":"10.1111\/jgh.14645","article-title":"Long-term efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study","volume":"34","author":"Kim","year":"2019","journal-title":"J Gastroenterol Hepatol."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"1699","DOI":"10.1016\/S0140-6736(18)32196-2","article-title":"Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn\u2019s disease: an international, randomised, double-blind, phase 3 non-inferiority study","volume":"393","author":"Ye","year":"2019","journal-title":"Lancet."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"99","DOI":"10.7326\/M18-1512","article-title":"Effectiveness and safety of reference infliximab and biosimilar in Crohn disease: a French equivalence study","volume":"170","author":"Meyer","year":"2019","journal-title":"Ann Intern Med."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"404","DOI":"10.1016\/S2468-1253(18)30082-7","article-title":"Serum concentrations after switching from originator infliximab to the biosimilar CT-P13 in patients with quiescent inflammatory bowel disease (SECURE): an open-label, multicentre, phase 4 non-inferiority trial","volume":"3","author":"Strik","year":"2018","journal-title":"Lancet Gastroenterol Hepatol."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"601","DOI":"10.1093\/ibd\/izx086","article-title":"Full interchangeability in regard to immunogenicity between the infliximab reference biologic and biosimilars CT-P13 and SB2 in inflammatory bowel disease","volume":"24","author":"Fiorino","year":"2018","journal-title":"Inflamm Bowel Dis."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"2506","DOI":"10.1016\/j.cgh.2018.12.036","article-title":"Outcomes of patients with inflammatory bowel diseases switched from maintenance therapy with a biosimilar to remicade","volume":"17","author":"Ilias","year":"2019","journal-title":"Clin Gastroenterol Hepatol."},{"key":"2023030920550655000_","article-title":"IBD biosimilar to biosimilar Infliximab switching study: preliminary results","author":"Harris"},{"key":"2023030920550655000_","doi-asserted-by":"crossref","article-title":"Switching infliximab biosimilar: no adverse impact on IBD control of drug levels with first or second switch","author":"Luber","DOI":"10.1016\/S0016-5085(20)31841-2"},{"key":"2023030920550655000_","article-title":"Safety and clinical efficacy of double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel disease (SCESICS); a multicentre study","author":"Mazza"},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"818","DOI":"10.1016\/j.cgh.2018.08.064","article-title":"Switching between biologics and biosimilars in inflammatory bowel disease","volume":"17","author":"Raffals","year":"2019","journal-title":"Clin Gastroenterol Hepatol."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"e1","DOI":"10.1093\/jcag\/gwz035","article-title":"Joint Canadian Association of Gastroenterology and Crohn\u2019s colitis Canada position statement on biosimilars for the treatment of inflammatory bowel disease","volume":"3","author":"Moayyedi","year":"2020","journal-title":"J Can Assoc Gastroenterol."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1093\/ecco-jcc\/jjw198","article-title":"ECCO position statement on the use of biosimilars for inflammatory bowel disease\u2014an update","volume":"11","author":"Danese","year":"2016","journal-title":"J Crohn\u2019s Colitis"},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"2163","DOI":"10.1001\/jama.2017.5202","article-title":"Obstacles to the adoption of biosimilars for chronic diseases","volume":"317","author":"Hakim","year":"2017","journal-title":"JAMA."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"E668","DOI":"10.1001\/amajethics.2019.668","article-title":"Why are biosimilars not living up to their promise in the US?","volume":"21","author":"Zhai","year":"2019","journal-title":"AMA J Ethics."},{"key":"2023030920550655000_","first-page":"952","article-title":"The biosimilar nocebo effect? A systematic review of double-blinded versus open-label studies","volume":"24","author":"Odinet","year":"2018","journal-title":"J Manag Care Spec Pharm."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"1372","DOI":"10.3389\/fphar.2019.01372","article-title":"The clinical implications of nocebo effects for biosimilar therapy","volume":"10","author":"Colloca","year":"2019","journal-title":"Front Pharmacol."},{"key":"2023030920550655000_","doi-asserted-by":"crossref","first-page":"2171","DOI":"10.1001\/jama.2019.16275","article-title":"Adalimumab and the challenges for biosimilars","volume":"322","author":"Gellad","year":"2019","journal-title":"JAMA"}],"container-title":["Crohn's &amp; Colitis 360"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article-pdf\/3\/1\/otaa093\/49482704\/otaa093.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article-pdf\/3\/1\/otaa093\/49482704\/otaa093.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,13]],"date-time":"2023-10-13T00:34:32Z","timestamp":1697157272000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article\/doi\/10.1093\/crocol\/otaa093\/6136168"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1,1]]},"references-count":26,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,1,1]]}},"URL":"https:\/\/doi.org\/10.1093\/crocol\/otaa093","relation":{},"ISSN":["2631-827X"],"issn-type":[{"value":"2631-827X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2021,1,1]]},"published":{"date-parts":[[2021,1,1]]},"article-number":"otaa093"}}