California and Illinois consider biosimilar substitution bills

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California and Illinois consider biosimilar substitution bills

INICIO/Políticas y legislación | Posted 20/03/2015 0 Post your comment

In the ongoing saga in the US over biosimilars substitution, California and Illinois are the latest states to be considering legislation which will allow the substitution of biosimilars at the pharmacy level.

In California, legislation was introduced on 27 February 2015 that closely mirrors compromise automatic substitution language supported by brand-name and biosimilar makers and unveiled by Generic Pharmaceutical Association (GPhA) in 2014 [1].

The California bill (SB-671) ‘would authorize a pharmacist to select an alternative biological product when filling a prescription order for a prescribed biological product if the alternative biological product is interchangeable, as defined, and the prescriber does not personally indicate “Do not substitute”.’

A previous attempt to pass legislation in California, Bill SB 598, that some believed would have impeded access to biosimilars, was vetoed by California Governor Jerry Brown in October 2013 [2].

The Illinois bill (HB 3519), on the other hand, which was introduced on 26 February 2015, would require pharmacies to notify prescribers of a substitution within three working days. The bill would also give the patient the option of rejecting the biosimilar version outright.

The Illinois bill also specifically states that a biosimilar may only be swapped if it costs less than the originator biological, unless the patient agrees to accept a higher-cost biosimilar.

Both bills only allow substitution of a biosimilar if the US Food and Drug Administration has approved the biosimilar as interchangeable, and also allow the prescribing physician to specifically state that no substitution should take place.

According to the National Conference of State Legislature, as of 31 December 2014, eight states have enacted legislation on biosimilars substitution, 13 other states had bills filed which did not pass and one state (New Jersey) had bills from 2014 carried over to 2015.

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

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.

Massachusetts governor signs biosimilars substitution bill

References
1. GaBI Online - Generics and Biosimilars Initiative. Compromise reached on US legislation on biosimilars substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20]. Available from: www.gabionline.net/Policies-Legislation/Compromise-reached-on-US-legislation-on-biosimilars-substitution
2. GaBI Online - Generics and Biosimilars Initiative. California governor vetoes biosimilars bill [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20]. Available from: www.gabionline.net/Policies-Legislation/California-governor-vetoes-biosimilars-bill

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Source: California State, Illinois state, NCSL