Regulation of biosimilar medicines and current perspectives on interchangeability and policy

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dc.contributor.author O'Callaghan, John
dc.contributor.author Barry, Sean P.
dc.contributor.author Bermingham, Margaret
dc.contributor.author Morris, J. Michael
dc.contributor.author Griffin, Brendan T.
dc.date.accessioned 2018-12-03T10:14:33Z
dc.date.available 2018-12-03T10:14:33Z
dc.date.issued 2018-09-05
dc.identifier.citation O'Callaghan, J., Barry, S. P., Bermingham, M., Morris, J. M. and Griffin, B. T. (2018) 'Regulation of biosimilar medicines and current perspectives on interchangeability and policy', European Journal of Clinical Pharmacology. doi:10.1007/s00228-018-2542-1 en
dc.identifier.issn 1432-1041
dc.identifier.issn 0031-6970
dc.identifier.uri http://hdl.handle.net/10468/7163
dc.identifier.doi 10.1007/s00228-018-2542-1
dc.description.abstract Competition arising from the increasing availability of biosimilar medicines has resulted in healthcare savings and has provided greater patient access to high cost therapeutics in Europe. The biosimilar market in the USA is relatively new so the full impact of biosimilar availability remains to be seen. Educational initiatives relating to the use of biosimilar medicines are currently being undertaken by regulators, policy makers and industry. The debate on biosimilars has moved on from the appropriateness of the regulatory framework which governs their approval, to the practice of interchangeability. Interchangeability is an important issue for healthcare professionals but different definitions and regulatory frameworks exist in the USA and Europe. In the USA, an interchangeable biological product is a biosimilar which may be substituted by a pharmacist, subject to local State policies. The interchangeability of a biosimilar with its reference medicine will be evaluated by the United States Food and Drug Administration (FDA) in cases where approval as an â interchangeable productâ is sought. In contrast, the European Medicines Agency (EMA) does not assess or make recommendations on interchangeability, therefore, in Europe, interchangeability does not mean substitution but is generally physician-led or driven by national policy. This paper provides an overview of the regulation of biosimilar medicines. Challenges associated with the demonstration of interchangeability and practical considerations relating to switching are also discussed. Finally, we present policies that have been adopted to date in several European countries, the USA and Australia, which aim to promote the use of biosimilar medicines. en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher Springer Nature Switzerland AG en
dc.rights © 2018, Springer-Verlag GmbH Germany, part of Springer Nature. All rights reserved. The final publication is available at Springer via http://dx.doi.org/10.1007/s00228-018-2542-1 en
dc.subject Regulation en
dc.subject Biosimilar en
dc.subject Policy en
dc.subject Interchangeability en
dc.subject Switching en
dc.subject Substitution en
dc.title Regulation of biosimilar medicines and current perspectives on interchangeability and policy en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Brendan Griffin, School Of Pharmacy, University College Cork, Cork, Ireland. +353-21-490-3000 Email: brendan.griffin@ucc.ie en
dc.internal.availability Full text available en
dc.check.info Access to this article is restricted until 12 months after publication by request of the publisher. en
dc.check.date 2019-09-05
dc.date.updated 2018-11-30T09:18:12Z
dc.description.version Accepted Version en
dc.internal.rssid 455847577
dc.contributor.funder University College Cork en
dc.contributor.funder Health Products Regulatory Authority, Ireland
dc.contributor.funder Regulatory Science Ireland
dc.contributor.funder Irish Pharmaceutical Healthcare Association
dc.description.status Peer reviewed en
dc.identifier.journaltitle European Journal of Clinical Pharmacology en
dc.internal.copyrightchecked Yes en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress Brendan.Griffin@ucc.ie en
dc.internal.bibliocheck In press. Check for vol. / issue / page numbers. Amend citation as necessary.


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