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Michigan latest state to pass biosimilars substitution law Posted 16/03/2018

The US Food and Drug Administration (FDA) gave marketing authorization to its first biosimilar in March 2015 [1]. To date, FDA has approved nine biosimilars [2]. All the products approved so far have been approved as biosimilars, not as interchangeable products. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

However, in anticipation of a biosimilar being approved as interchangeable, many US states are considering, or have introduced, laws related to the substitution of biosimilars at the pharmacy level [3]. The latest state to enact a law allowing the substitution of biosimilars at the pharmacy level is Michigan.

Governor Rick Snyder signed House Bill 4472 into law on 1 March 2018. The Michigan Senate passed the bill in February with a vote of 34−0 (4 abstentions). This was preceded by an almost unanimous vote (105−1) on the same bill in the House.

The Michigan bill authorizes a pharmacist to substitute a biosimilar for a prescribed biological product if the biosimilar has been approved by 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 [4].

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 Biotechnology Innovation Organization (BIO) and MichBio have both commended Governor Rick Snyder ‘for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines, with appropriate communication to patients and physicians’.

Editor’s Comment
Readers interested to learn more about 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

GaBI Journal is indexed in Embase, Scopus, Thomson Reuters’ ESCI, and more.

Contribute a research or review paper to GaBI Journal – an independent, peer reviewed academic journal – send us your submission here

Related articles
Idaho governor signs biosimilars substitution bill

Oregon passes biosimilars substitution law

Kentucky Senate passes biosimilars substitution bill

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 16]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3.  Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
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 2018 Mar 16]. Available from: www.gabionline.net/Policies-Legislation/Compromise-reached-on-US-legislation-on-biosimilars-substitution

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Source: Business Wire, Legiscan

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