Substitution and interchangeability: time for a conversation?

Category: Commentary
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Keywords: Australia, interchangeability, substitution

Author byline as per print journal: Chad Rieger, MBA; Lisa Hall, PhD; David Lim, DPH

Abstract:
Bandiera et al. (2002) identified the potential for competitors’ promotional materials to use certain terms with technical meanings, such as ‘interchangeable’ and ‘substitution’, in a misleading way in Australia. 

The blurring of language used within the Australian Pharmaceutical Benefits Scheme (PBS) and the conflicting elements within the system contribute to the resultant tenuous uptake of biosimilar medicines in Australia.

Whilst ‘substitution’ and ‘interchangeability’ are likely to represent the same thing in the clinicians’ and consumers’ minds when it comes to small molecule generics, there is a real likelihood of confusion and subsequent delay in biosimilars uptake in Australia where such terms are used [1, 2]. The potential for confusion between ‘substitution’ and ‘interchangeability’ has real implications for the uptake of biosimilars in Australia and other countries where there is a lack of legislative definition and/or clarity of what ‘interchangeability’ entails.

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. 

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