Biosimilars substitution bills become law in four US states

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The latest states to enact laws that allow the substitution of biosimilars at the pharmacy level include Georgia, North Carolina, Tennessee and Washington.

Application V15a16

In Georgia, Governor Deal signed Senate Bill 51 into law on 6 May 2015. The Georgia Senate passed the bill in March with a vote of 43–3. This was preceded by a unanimous vote on the same bill in the House.

In North Carolina, Governor McCrory signed House Bill 195 into law on 21 May 2015. The signing followed a unanimous passage in the North Carolina Senate the week before, and was preceded by a House vote of 101–6 in April.

In Tennessee, Governor Haslam signed the legislation into law on 4 May 2015. Senate Bill 984 was unanimously passed in both the Tennessee House of Representatives and Senate in April.

In Washington, Governor Inslee signed Senate Bill 5935 into law on 11 May 2015. The Washington Senate passed the legislation in April with a vote of 47–1, preceded by a vote of 96–1 on the same bill in the House.

The bills closely mirror compromise automatic substitution language supported by brand-name and biosimilar makers and unveiled by the Generic Pharmaceutical Association (GPhA) in 2014 [1].

The GPhA has applauded states that use the compromise wording as ‘passing laws that create a competitive market for biosimilar products and provide patient access to affordable versions of these critical medicines’. The association is also ‘pleased these states have embraced a framework for these new medicines that reflects our organizations’ core principles: uphold the current pharmacy practice of automatic substitution; rely on the science-based determination of interchangeability by the Food and Drug Administration (FDA); and treat interchangeables and their corresponding brand biologic[al]s the same during dispensing at the pharmacy’.

Editor’s Comment
Readers interested to learn more about US state legislation and biosimilarity and interchangeability in the US are invited to visit to view the following manuscripts published in GaBI Journal:

Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act

US state legislation on biosimilars substitution

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

Related articles
California and Illinois consider biosimilar substitution bills

Idaho proposes legislation on biosimilars substitution

Massachusetts governor signs biosimilars substitution bill

Indiana biosimilars substitution bill becomes law

1. GaBI Online - Generics and Biosimilars Initiative. Compromise reached on US legislation on biosimilars substitution []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 19]. Available from:

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Source: Legiscan

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