Oregon is the latest US state to pass a law 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].
Oregon Governor Kate Brown signed House Bill 4105 (HB4105) into law on 14 March 2016, following passage in the Oregon House and Senate on 1 and 2 March 2016, respectively.
The bill authorizes 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 ‘interchangeable’. In addition, substitution will only be allowed if the prescriber has not designated on the prescription that substitution is prohibited.
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 HB4105 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 bill also requires that the pharmacy or pharmacist retains a record of the substitution for a period of not less than three years.
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
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
Kentucky Senate passes biosimilars substitution bill
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 18]. 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 18]. 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 18]. 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 18]. Available from: www.gabionline.net/Policies-Legislation/Compromise-reached-on-US-legislation-on-biosimilars-substitution
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