Texas is the latest US state to pass a law that will allow the substitution of biosimilars at the pharmacy level. To date, thirteen states have passed legislation requiring prescriber communication and record keeping for biosimilars [1].
Governor Greg Abbott signed House Bill 751 into law on 19 June 2015, following passage in the Texas House and Senate on 31 May and 1 June 2015, respectively.
The bill closely mirror compromise automatic substitution language supported by brand-name and biosimilars makers and unveiled by the Generic Pharmaceutical Association (GPhA) in 2014 [2]. The compromise wording allows ‘a reasonable time’ for communication of any substitution to the prescriber and allows this to be done via the use of an interoperable electronic 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’.
The Biotechnology Industry Organization (BIO) and the Texas Healthcare & Bioscience Institute (THBI) also commended the Texas governor for ‘signing critical legislation to create a pathway for the substitution of interchangeable biologic[al] medicines’. Mr Jim Greenwood, BIO’s President and Chief Executive Officer, added that the bill ‘includes communication on all biologic[al] medicines dispensed in order to maintain a consistent and complete medical record’.
The new bill comes into effect on 1 September 2015.
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
Biosimilars substitution bills become law in four US states
California and Illinois consider biosimilar substitution bills
Idaho proposes legislation on biosimilars substitution
Massachusetts governor signs biosimilars substitution bill
Indiana biosimilars substitution bill becomes law
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. Compromise reached on US legislation on biosimilars substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jul 3]. Available from: www.gabionline.net/Policies-Legislation/Compromise-reached-on-US-legislation-on-biosimilars-substitution
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