New Jersey is the latest US state to pass a law 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 [1-3].
New Jersey Governor Chris Christie signed Assembly Bill 2477 into law on 9 November 2015, following unanimous passage in the New Jersey Senate and Assembly earlier in the year.
The New Jersey 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 as interchangeable and the prescriber has not indicated ‘do not substitute’.
The bill does not use compromise automatic substitution language supported by brand-name biologicals and biosimilars makers unveiled by the Generic Pharmaceutical Association (GPhA) in 2014 [4]. However, the GPhA and its Biosimilars Council have still applauded Governor Christie for signing New Jersey A2477 into law, thus ‘allowing interchangeable biologic[al] substitution at the pharmacy’.
The A2477 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 also requires records to be kept for at least five years after the dispensing date.
The GPhA has praised 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’.
The Biotechnology Industry Organization (BIO) commended the New Jersey governor for ‘signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines’. The organization added that ‘the bill align with BIO’s principles on biologic[al] substitution’.
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 2015 Dec 4]. 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 2015 Dec 4]. Available from: www.gabionline.net/Policies-Legislation/Biosimilars-substitution-bill-becomes-law-in-California
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 2015 Dec 4]. Available from: www.gabionline.net/Policies-Legislation/Compromise-reached-on-US-legislation-on-biosimilars-substitution
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