Biosimilars substitution bill becomes law in California

INICIO/Políticas y legislación | Posted 23/10/2015 post-comment0 Post your comment

California is the latest US state to pass a law that will allow the substitution of biosimilars at the pharmacy level. To date, 14 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1, 2].

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California Governor Jerry Brown signed Senate Bill 671 into law on 6 October 2015, following passage in the California Senate and Assembly. 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 [3].

The latest 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”.’

The bill closely mirrors compromise automatic substitution language supported by brand-name and biosimilars makers and unveiled by the Generic Pharmaceutical Association (GPhA) in 2014 [4]. The compromise wording allows for communication of any substitution to the prescriber and allows this to be done via the use of an interoperable electronic system, thus reducing the burden on pharmacists. The SB‑671 bill does, however, differ from the compromise wording in requiring communication within five days of dispensing the biosimilar, rather than ‘within a reasonable time’, as advocated by the GPhA.

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 Biotechnology Industry Organization (BIO) commended the Californian governor for ‘signing critical legislation to create a pathway for the substitution of interchangeable biologic[al] medicines’. Jim Greenwood, BIO’s President and Chief Executive Officer, added that the bill ‘includes communication on all biologic[al] medicines dispensed in order to maintain a consistent and complete medical record’.

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:

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

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 article
California and Illinois consider biosimilar substitution bills

References
1.   Derbyshire M. Update on US state legislation on biosimilars substitution. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(2):95-7. doi:10.5639/gabij.2015.0402.020
2.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars substitution bill become law in Texas [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 23]. Available from: www.gabionline.net/Policies-Legislation/Biosimilars-substitution-bill-become-law-in-Texas
3.   GaBI Online - Generics and Biosimilars Initiative. California governor vetoes biosimilars bill [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 23]. Available from: www.gabionline.net/Policies-Legislation/California-governor-vetoes-biosimilars-bill
4.   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 Oct 23]. Available from: www.gabionline.net/Policies-Legislation/Compromise-reached-on-US-legislation-on-biosimilars-substitution

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Source: BIO,LegInfo

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