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Kentucky Senate passes biosimilars substitution bill Posted 11/03/2016

The Kentucky Senate is the latest US state to pass a bill that will allow the substitution of biosimilars at the pharmacy level. To date, 15 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1-4].

The bipartisan bill (SB134) was passed unanimously by the Kentucky Senate on 2 March 2016 in a 36−1 vote. The bill has now been referred to the House Committee on Health & Welfare

The Kentucky bill, if approved, will authorize a pharmacist to substitute a biosimilar for a prescribed biological product if the biosimilar has been approved by the US Food and Drug administration (FDA) as ‘therapeutically equivalent’ and ‘meets the standards for interchangeability’. In addition, substitution will only be allowed if the prescriber has not indicated ‘Do Not Substitute’ on the prescription.

The bill does not use compromise automatic substitution language supported by brand-name and biosimilars makers and unveiled by the Generic Pharmaceutical Association (GPhA) in 2014 [5].

The SB134 bill differs from the compromise wording in requiring communication within five business days of dispensing the biosimilar, rather than ‘within a reasonable time’, as advocated by the GPhA. The bill, however, does allow the use of an interoperable electronic medical records system, thus reducing the burden on pharmacists.

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’.

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 articles
Biosimilars substitution bills become law in four US states

More US state legislation on biosimilars substitution

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 2016 Mar 11]. Available from: www.gabionline.net/Policies-Legislation/Biosimilars-substitution-bill-become-law-in-Texas
3.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars substitution bill become law in California [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 11]. Available from: www.gabionline.net/Policies-Legislation/Biosimilars-substitution-bill-becomes-law-in-California
4.   GaBI Online - Generics and Biosimilars Initiative. New Jersey passes biosimilars substitution bill [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 11]. Available from: www.gabionline.net/Policies-Legislation/New-Jersey-passes-biosimilars-substitution-bill
5.   GaBI Online - Generics and Biosimilars Initiative. Compromise reached on US legislation on biosimilars substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 11]. Available from: www.gabionline.net/Policies-Legislation/Compromise-reached-on-US-legislation-on-biosimilars-substitution

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