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dc.contributor.authorCarroll, Donal
dc.contributor.authorO'Brien, Gary
dc.contributor.authorMulcahy, Mark
dc.contributor.authorCourtney, Garry
dc.contributor.authorByrne, Stephen
dc.contributor.authorWalshe, Valerie
dc.date.accessioned2018-09-18T16:39:06Z
dc.date.available2018-09-18T16:39:06Z
dc.date.issued2018-02-27
dc.identifier.doi10.5639/gabij.2018.0701.004
dc.identifier.urihttp://hdl.handle.net/10147/623795
dc.description.abstractBackground and aim: Biosimilar medicines are not considered exact replicas of originator biological medicines. As a result, prescribers can be hesitant to introduce such medicines into the clinical setting until evidence surfaces confirming their safety and effectiveness. In Ireland, a national biosimilar medicines policy is currently in development but the decision to prescribe biosimilar medicines remains at the discretion of the physician. The aim of this descriptive review is to tell the story of the evidence used by a large acute Irish teaching hospital to introduce biosimilar infliximab CT-P13 for the treatment of inflammatory bowel disease (IBD) in a safe and timely manner into routine care. Methods: To explore the evidence supporting the effective introduction of biosimilar infliximab in a large acute Irish teaching hospital, a literature review was conducted. Evidence consisted of published studies, reviews, reports, position statements, articles, clinical guidelines, and recommendations from national bodies, regulatory authorities and professional organizations. All evidence was published in English. Results and discussion: In September 2014, the accumulated evidence base provided physicians with reassurance to prescribe biosimilar infliximab CT-P13 for new patients suffering from IBD in this large acute Irish teaching hospital. In September 2016, as the evidence base grew, physicians began to safely and confidently switch patients from the originator infliximab product to the biosimilar product. Conclusion: There was a significant time lag between regulatory approval and clinical acceptance given that the European Medicines Agency had granted market authorization for biosimilar infliximab CT-P13 three years prior to the initiation of this hospital’s switching process. Although conservative in their execution, the authors conclude that with the existential concern and uncertainty still surrounding biosimilar medicines, a distinct and individualized approach for biosimilar medicine implementation is required. It is with hope that the Irish biosimilar medicines policy will improve upon biosimilar medicine clinical acceptance once published.en_US
dc.description.sponsorshipIrish Research Council GOIPG/2016/635en_US
dc.language.isoenen_US
dc.publisherPro Pharma Communications Internationalen_US
dc.relation.urlhttp://gabi-journal.net/biosimilar-infliximab-introduction-into-the-gastroenterology-care-pathway-in-a-large-acute-irish-teaching-hospital-a-story-behind-the-evidence.htmlen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.subjectINFLAMMATORY BOWEL DISEASEen_US
dc.subjectGASTROENTEROLOGYen_US
dc.titleBiosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidenceen_US
dc.typeArticleen_US
dc.contributor.departmentPharmaceutical Care Research Group, School of Pharmacy, University College Cork, College Road, Ireland/St Luke’s General Hospital, Freshford Road, Kilkenny, Ireland/Department of Accounting, Finance and Information Systems, Cork University Business Schools, University College Cork, College Road, Ireland/Cost Accounting & Funding Team, National Finance Division, Health Service Executive, First Floor East, Model Business Park, Model Farm Road, Cork, Irelanden_US
dc.identifier.journalGenerics and Biosimilars Initiative Journal (GaBI Journal)en_US
dc.description.fundingIRCSET IRC Science Eng Techen_US
dc.description.provinceLeinsteren_US
dc.description.peer-reviewpeer-reviewen_US


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