Massachusetts has become the latest US state to pass a law allowing substitution of a biosimilar for an originator biological, but with certain restrictions.
Massachusetts Governor Deval Patrick signed into law House Bill 3734 (Senate Bill 2176) on 24 June 2014.
The bill allows pharmacists to substitute US Food and Drug Administration (FDA) approved interchangeable biosimilars for prescribed biological reference products unless the prescriber instructs otherwise in writing. The law also requires that the pharmacist informs the patient of the substitution and notifies the physician in writing ‘within a reasonable time’ of the substitution. The pharmacy must also maintain a written or electronic record of any such substitutions for at least one year.
The Biotechnology Industry Organization (BIO), which represents originator biologicals companies, and the non-profit trade association Massachusetts Biotechnology Council (MassBio) issued a statement in support of the legislation. The groups said that ‘Massachusetts is leading the way in adopting policy that not only supports a growing industry, but more importantly allows patients access to the most cutting-edge therapies that have been proven safe and effective’.
The Generic Pharmaceutical Association (GPhA) also applauded the Massachusetts state legislature. The association added that ‘laws that avoid unnecessary requirements around these new medicines not only increase patient access, but also will enable public and private payers to achieve significant savings by facilitating substitution of interchangeable biologic[al]s for more expensive versions. Massachusetts provides a compelling example of policy that embraces a practical approach’.
The GPhA has been against such US state legislation in the past, given the fact that FDA is yet to issue final guidance or receive a biosimilars application. The GPhA has stated that laws concerning biosimilar substitution are ‘premature and unnecessary at this time’ [1].
The reason for the GPhA endorsement of the Massachusetts legislation is perhaps due to the fact that the wording of the physician notification is also much less strict than in some other states and the period of record keeping much shorter. For example, North Dakota requires notification within one day and Mississippi requires records of the substitution to be kept for 10 years [2].
The Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilar medicines companies in the US, also commended the new law. Dr Richard O Dolinar, Chairman of the ASBM, stated that the law ‘strikes the right balance in maintaining the safety and efficacy of biologic[al] products, while advancing more treatment options to patients’.
Related articles
Delaware passes biosimilars substitution law
Indiana biosimilars substitution bill becomes law
California governor vetoes biosimilars bill
References
1. GaBI Online - Generics and Biosimilars Initiative. US state legislation on biosimilars substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 June 27]. Available from: www.gabionline.net/Policies-Legislation/US-state-legislation-on-biosimilars-substitution
2. Derbyshire M. US state legislation on biosimilars substitution. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(3):155-6. doi:10.5639/gabij.2013.0203.040
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Source: ASBM, BIO, GPhA, Massachusetts State Senate
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