Biosimilar infliximab introduction into the gastro-enterology care pathway in a large acute Irish teaching hospital: a story behind the evidence

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dc.contributor.authorO'Brien, Gary L.
dc.contributor.authorCarrol, Donal
dc.contributor.authorMulcahy, Mark
dc.contributor.authorWalshe, Valerie
dc.contributor.authorCourtney, Garry
dc.contributor.authorByrne, Stephen
dc.contributor.funderIrish Research Councilen
dc.date.accessioned2018-08-14T09:50:30Z
dc.date.available2018-08-14T09:50:30Z
dc.date.issued2018-02-27
dc.date.updated2018-08-14T09:41:29Z
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
dc.description.sponsorshipIrish Research Council (GOIPG/2016/635)en
dc.description.statusPeer revieweden
dc.description.versionAccepted Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationO'Brien, G. L., Carrol, D., Mulcahy, M., Walshe, V., Courtney, G. and Byrne, S. (2018) 'Biosimilar infliximab introduction into the gastro-enterology care pathway in a large acute Irish teaching hospital: a story behind the evidence', Generics and Biosimilars Initiative Journal (GaBI Journal), 7(1), pp. 14-21. doi:10.5639/gabij.2018.0701.004en
dc.identifier.doi10.5639/gabij.2018.0701.004
dc.identifier.endpage21en
dc.identifier.issn2033-6403
dc.identifier.issn2033-6772
dc.identifier.issued1en
dc.identifier.journaltitleGenerics and Biosimilars Initiative Journal (GaBI Journal)en
dc.identifier.startpage14en
dc.identifier.urihttps://hdl.handle.net/10468/6603
dc.identifier.volume7en
dc.language.isoenen
dc.publisherPro Pharma Communications Internationalen
dc.rights© 2018, Pro Pharma Communications International. All rights reserved. The original publication is available at www.gabi-journal.neten
dc.subjectBiologicsen
dc.subjectEvidence-baseden
dc.subjectInflammatory bowel diseaseen
dc.subjectIBDen
dc.subjectSecondary careen
dc.subjectSwitchingen
dc.titleBiosimilar infliximab introduction into the gastro-enterology care pathway in a large acute Irish teaching hospital: a story behind the evidenceen
dc.typeArticle (peer-reviewed)en
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