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.author O'Brien, Gary L.
dc.contributor.author Carrol, Donal
dc.contributor.author Mulcahy, Mark
dc.contributor.author Walshe, Valerie
dc.contributor.author Courtney, Garry
dc.contributor.author Byrne, Stephen
dc.date.accessioned 2018-08-14T09:50:30Z
dc.date.available 2018-08-14T09:50:30Z
dc.date.issued 2018-02-27
dc.identifier.citation O'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.2018.0701.004 en
dc.identifier.volume 7 en
dc.identifier.issued 1 en
dc.identifier.startpage 14 en
dc.identifier.endpage 21 en
dc.identifier.issn 2033-6403
dc.identifier.issn 2033-6772
dc.identifier.uri http://hdl.handle.net/10468/6603
dc.identifier.doi 10.5639/gabij.2018.0701.004
dc.description.abstract Background 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.sponsorship Irish Research Council (GOIPG/2016/635) en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher Pro Pharma Communications International en
dc.rights © 2018, Pro Pharma Communications International. All rights reserved. The original publication is available at www.gabi-journal.net en
dc.subject Biologics en
dc.subject Evidence-based en
dc.subject Inflammatory bowel disease en
dc.subject IBD en
dc.subject Secondary care en
dc.subject Switching en
dc.title Biosimilar infliximab introduction into the gastro-enterology care pathway in a large acute Irish teaching hospital: a story behind the evidence en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Stephen Byrne, School Of Pharmacy, University College Cork, Cork, Ireland. +353-21-490-3000 Email: stephen.byrne@ucc.ie en
dc.internal.availability Full text available en
dc.date.updated 2018-08-14T09:41:29Z
dc.description.version Accepted Version en
dc.internal.rssid 449514133
dc.contributor.funder Irish Research Council en
dc.description.status Peer reviewed en
dc.identifier.journaltitle Generics and Biosimilars Initiative Journal (GaBI Journal) en
dc.internal.copyrightchecked Yes en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress Stephen.Byrne@ucc.ie en


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