Regulation of biosimilar medicines and current perspectives on interchangeability and policy

O'Callaghan, John; Barry, Sean P.; Bermingham, Margaret; Morris, J. Michael; Griffin, Brendan T.

Access to this article is restricted until 12 months after publication by request of the publisher.. Restriction lift date: 2019-09-05

Regulation of biosimilar medicines and current perspectives on interchangeability and policy

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dc.check.date	2019-09-05
dc.check.info	Access to this article is restricted until 12 months after publication by request of the publisher.	en
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.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.date.accessioned	2018-12-03T10:14:33Z
dc.date.available	2018-12-03T10:14:33Z
dc.date.issued	2018-09-05
dc.date.updated	2018-11-30T09:18:12Z
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.description.status	Peer reviewed	en
dc.description.version	Accepted Version	en
dc.format.mimetype	application/pdf	en
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.doi	10.1007/s00228-018-2542-1
dc.identifier.issn	1432-1041
dc.identifier.issn	0031-6970
dc.identifier.journaltitle	European Journal of Clinical Pharmacology	en
dc.identifier.uri	https://hdl.handle.net/10468/7163
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