Interchangeability of biosimilars around the world

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There is a lack of harmonization around the world when it comes to how different countries or regions approach interchangeability of biosimilars [1].

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In the US interchangeability is defined in law as part of the Biologics Price Competition and Innovation Act.

The US Food and Drug Administration may approve a product as interchangeable. Although individual states control the act of pharmacy-level substitution.

European Union
The European Commission has defined interchangeability in a consensus information document on biosimilars [4].

In the European Union, decisions on the interchangeability or substitution of biosimilars and originator biologicals are not made by the European Medicines Agency, but at the national level.

In Canada, where biosimilars were previously referred to as subsequent entry biologics, the medicines regulatory agency Health Canada has not defined interchangeability for biosimilars.

Health Canada does not designate biosimilars as interchangeable and does not support automatic substitution. Decisions on interchangeability are made at the province level.

Australia’s Pharmaceutical Benefits Advisory Committee can designate biosimilars as interchangeable, known as ‘a-flagging’. 

In Australia the payer body has the exclusive authority to determine substitution of biosimilars at the pharmacy level. The substitution of biosimilars is recommended as its default policy.

The lack of harmonization for the interchangeability of biosimilars across the world introduces confusion for stakeholders and developers.

Editor’s comment
This article for GaBI Online is a summary of the full article [1] published in GaBI Journal.

If you would like to receive a copy of the GaBI Journal article, please send us an email.

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Interchangeability of biosimilars in the US

The evolution of biosimilars in the US 

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1. Derbyshire M. Interchangeability of biosimilars in the US and around the world. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(2):97-8. doi:10.5639/gabij.2017.0602.017

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