Biosimilars for Management of Crohn Disease
Authors: Ole Haagen Nielsen, Mark Andrew Ainsworth
Journal: Annals of Internal Medicine (2018)

Editorials15 January 2019Biosimilars for Management of Crohn DiseaseOle Haagen Nielsen, MD, DMSc and Mark Andrew Ainsworth, MD, PhD, DMScOle Haagen Nielsen, MD, DMScUniversity of Copenhagen Herlev Hospital, Herlev, Denmark (O.H.N.) and Mark Andrew Ainsworth, MD, PhD, DMScOdense University Hospital, Odense, Denmark (M.A.A.)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M18-3060 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Inhibitors of tumor necrosis factor-α have revolutionized management of Crohn disease (1). Since the approval of infliximab, a monoclonal chimeric antibody, by the U.S. Food and Drug Administration in August 1998 and the European Medicines Agency in August 1999, millions of patients have been treated with it for inflammatory disorders, including Crohn disease. This drug and subsequently marketed biologics have substantially changed therapy for these potentially debilitating disorders and have transformed treatment paradigms from focusing on symptom control only to also aiming to heal the mucosa and preserve intestinal function (2). However, the gains have come at a price. The ...References1. Nielsen OH, Ainsworth MA. Tumor necrosis factor inhibitors for inflammatory bowel disease. N Engl J Med. 2013;369:754-62. [PMID: 23964937] doi:10.1056/NEJMct1209614 CrossrefMedlineGoogle Scholar2. Rogler G. Resolution of inflammation in inflammatory bowel disease. Lancet Gastroenterol Hepatol. 2017;2:521-30. [PMID: 28606878] doi:10.1016/S2468-1253(17)30031-6 CrossrefMedlineGoogle Scholar3. Nisen M. The best selling prescription drugs in the world last year. Quartz. 25 February 2015. Accessed at https://qz.com/349929/best-selling-drugs-in-the-world on 2 November 2018. Google Scholar4. Beyer B, Walch N, Jungbauer A, Lingg N. How similar is biosimilar? A comparison of infliximab therapeutics in regard to charge variant profile and antigen binding affinity. Biotechnol J. 2018:e1800340. [PMID: 30315690] doi:10.1002/biot.201800340 CrossrefMedlineGoogle Scholar5. Kang J, Pisupati K, Benet A, Ruotolo BT, Schwendeman SP, Schwendeman A. Infliximab biosimilars in the age of personalized medicine. Trends Biotechnol. 2018;36:987-92. [PMID: 29861288] doi:10.1016/j.tibtech.2018.05.002 CrossrefMedlineGoogle Scholar6. Ebbers HC. Biosimilars: in support of extrapolation of indications. J Crohns Colitis. 2014;8:431-5. [PMID: 24594005] doi:10.1016/j.crohns.2014.02.007 CrossrefMedlineGoogle Scholar7. Bergqvist V, Kadivar M, Molin D, Angelison L, Hammarlund P, Olin M, et al. Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease. Therap Adv Gastroenterol. 2018;11:1756284818801244. [PMID: 30344642] doi:10.1177/1756284818801244 CrossrefMedlineGoogle Scholar8. Meyer A, Rudant J, Drouin J, Weill A, Carbonnel F, Coste J. Effectiveness and safety of reference infliximab and biosimilar in Crohn disease. A French equivalence study. Ann Intern Med. 2019;170:99-107. doi:10.7326/M18-1512 LinkGoogle Scholar9. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Rand Health Q. 2018;7:3. [PMID: 30083415] MedlineGoogle Scholar10. Jacobs I, Singh E, Sewell KL, Al-Sabbagh A, Shane LG. Patient attitudes and understanding about biosimilars: an international cross-sectional survey. Patient Prefer Adherence. 2016;10:937-48. [PMID: 27307714] doi:10.2147/PPA.S104891 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: University of Copenhagen Herlev Hospital, Herlev, Denmark (O.H.N.)Odense University Hospital, Odense, Denmark (M.A.A.)Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-3060.Corresponding Author: Ole Haagen Nielsen, MD, DMSc, Department of Gastroenterology, Herlev Hospital, Medical Section D112M, 75 Herlev Ringvej, DK-2730 Herlev, Denmark; e-mail, ole.haagen.[email protected]dk.Current Author Addresses: Dr. Nielsen: Department of Gastroenterology, Herlev Hospital, Medical Section D112M, 75 Herlev Ringvej, DK-2730 Herlev, Denmark.Dr. Ainsworth: Department of Gastroenterology, Odense University Hospital, J.B. Winsløws Vej 4, DK-5000 Odense C, Denmark.This article was published at Annals.org on 11 December 2018. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoEffectiveness and Safety of Reference Infliximab and Biosimilar in Crohn Disease: A French Equivalence Study Antoine Meyer , Jérémie Rudant , Jérôme Drouin , Alain Weill , Franck Carbonnel , and Joël Coste Metrics Cited byEfficacy and safety of methotrexate in the management of inflammatory bowel disease: A systematic review and meta-analysis of randomized, controlled trialsSMAC mimetics and RIPK inhibitors as therapeutics for chronic inflammatory diseases 15 January 2019Volume 170, Issue 2Page: 129-130KeywordsBiologicsClinical trialsCohort studiesCrohn's diseaseDrugsExerciseHealth carePatientsSafetySafety studies ePublished: 11 December 2018 Issue Published: 15 January 2019 Copyright & PermissionsCopyright © 2018 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...