Idaho governor signs biosimilars substitution bill

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Idaho governor signs biosimilars substitution bill

INICIO/Políticas y legislación | Posted 01/04/2016 0 Post your comment

Idaho is the latest US state to pass a bill that will allow the substitution of biosimilars at the pharmacy level. To date, 16 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1-4].

Governor Clement Leroy ‘Butch’ Otter signed the Idaho House Bill 483 (H0483) into law on 25 March 2016.

The bill was passed by the Idaho House on 1 March 2016 in a 54-15-1 vote and by the Idaho Senate on 15 March 2016 in a 32-2-1 vote.

The Idaho bill 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 that ‘meets the standards for interchangeability’. In addition, the bill has a sunset date of 1 July 2026, after which the provisions of the bill will be null, void and of no force and effect.

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 HO483 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:

Update on 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

More US state legislation on biosimilars substitution

Idaho proposes legislation on biosimilars substitution

Source: Legiscan

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 Apr 1]. 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 Apr 1]. 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 Apr 1]. 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 Apr 1]. Available from: www.gabionline.net/Policies-Legislation/Compromise-reached-on-US-legislation-on-biosimilars-substitution

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