Michigan is the latest US state to introduce 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 new bill (HB 4812) was referred to the Michigan House Committee on Health Policy on 1 December 2015. HB 4812 replaces a previous Michigan bill on biosimilars (HB 4437), which required physician notification of substitution before dispensing [1].
The Michigan 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 the prescriber has not indicated ‘d.a.w.’ (dispense as written) 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 HB 4812 bill differs 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 bill, however, does allow the use of an interoperable electronic medical records system, thus reducing the burden on pharmacists.
The Alliance for Safe Biologic Medicines (ASBM), an organization composed of diverse healthcare groups and individuals – from patients to physicians, innovative medical biotechnology companies and others – who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion, has written to Mike Callton the Michigan House Health Policy Committee Chairman asking him to support the bill. They add that ‘communication between patients, pharmacists and healthcare providers is essential to patient care’ and ‘are concerned that patient safety will be compromised if this legislation is not enacted’.
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 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 2016 Jan 15]. 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 Jan 15]. 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 Jan 15]. 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 Jan 15]. Available from: www.gabionline.net/Policies-Legislation/Compromise-reached-on-US-legislation-on-biosimilars-substitution
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