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dc.contributor.authorMcKinnon, Ross A
dc.contributor.authorCook, Matthew
dc.contributor.authorLiauw, Winston
dc.contributor.authorMarabani, Mona
dc.contributor.authorMarschner, Ian C
dc.contributor.authorPacker, Nicolle H
dc.contributor.authorPrins, Johannes B
dc.date.accessioned2018-03-22T05:30:19Z
dc.date.available2018-03-22T05:30:19Z
dc.date.issued2018-01-17
dc.identifier.citationMcKinnon, R. A., Cook, M., Liauw, W., Marabani, M., Marschner, I. C., Packer, N. H., & Prins, J. B. (2018). Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review. BioDrugs, 32(1), 27–52. https://doi.org/10.1007/s40259-017-0256-zen
dc.identifier.issn1173-8804
dc.identifier.urihttp://hdl.handle.net/2328/37806
dc.descriptionThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.en_US
dc.description.abstractBackground The efficacy, safety and immunogenicity risk of switching between an originator biologic and a biosimilar or from one biosimilar to another are of potential concern. Objectives The aim was to conduct a systematic literature review of the outcomes of switching between biologics and their biosimilars and identify any evidence gaps. Methods A systematic literature search was conducted in PubMed, EMBASE and Cochrane Library from inception to June 2017. Relevant societal meetings were also checked. Peer-reviewed studies reporting efficacy and/or safety data on switching between originator and biosimilar products or from one biosimilar to another were selected. Studies with fewer than 20 switched patients were excluded. Data were extracted on interventions, study population, reason for treatment switching, efficacy outcomes, safety and anti-drug antibodies. Results The systematic literature search identified 63 primary publications covering 57 switching studies. The reason for switching was reported as non-medical in 50 studies (23 clinical, 27 observational). Seven studies (all observational) did not report whether the reasons for switching were medical or non-medical. In 38 of the 57 studies, fewer than 100 patients were switched. Follow-up after switching went beyond 1 year in eight of the 57 studies. Of the 57 studies, 33 included statistical analysis of disease activity or patient outcomes; the majority of these studies found no statistically significant differences between groups for main efficacy parameters (based on P < 0.05 or predefined acceptance ranges), although some studies observed changes for some parameters. Most studies reported similar safety profiles between groups. Conclusions There are important evidence gaps around the safety of switching between biologics and their biosimilars. Sufficiently powered and appropriately statistically analysed clinical trials and pharmacovigilance studies, with long-term follow-ups and multiple switches, are needed to support decision-making around biosimilar switching.en_US
dc.language.isoen
dc.publisherSpringeren
dc.rights© The Author(s) 2018en
dc.subjectimmunogenicity risken
dc.subjectSystematic Reviewen
dc.subjectbiologicsen
dc.subjectbiosimilarsen
dc.titleBiosimilarity and Interchangeability: Principles and Evidence: A Systematic Reviewen
dc.typeArticleen
dc.identifier.doihttps://doi.org/10.1007/s40259-017-0256-zen
dc.rights.holderThe Author(s)en
local.contributor.authorOrcidLookupMcKinnon, Ross A: https://orcid.org/0000-0002-3725-793Xen_US


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