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 and two follow-on biologicals [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 US states to enact laws allowing the substitution of biosimilars at the pharmacy level are South Dakota, West Virginia and Wisconsin.
In South Dakota, Governor Dennis Daugaard signed Senate Bill 75 into law on 8 February 2018. The South Dakota House passed the bill in January with a unanimous vote of 68−0 (with 2 abstentions). This was preceded by a unanimous vote on the same bill in the Senate (34-0, 1 abstention).
In West Virginia, Governor Jim Justice signed House Bill 4524 into law on 27 March 2018. The West Virginia House and Senate both passed the bill earlier in March with unanimous votes (97:0 and 33:0, respectively).
In Wisconsin, Governor Scott Walker signed Senate Bill 575 into law on 28 March 2018.
The bills authorize a pharmacist to substitute a biosimilar for a prescribed biological product if the biosimilar has been approved by FDA as ‘interchangeable’. In addition, substitution will only be allowed if the prescriber has not designated on the prescription that substitution is prohibited. For example, where the prescriber writes ‘brand necessary’, ‘no substitutions’, ‘NS’ or words of similar meaning on the prescription.
The bills do not use compromise automatic substitution language supported by brand-name and biosimilars makers, and unveiled by the Association for Accessible Medicines (AAM) (formerly the Generic Pharmaceutical Association) in 2014 [4].
The bills differ from the compromise wording in requiring communication within five business days of dispensing the biosimilar, rather than ‘within a reasonable time’, as advocated by the AAM. The bills do, however, allow the use of an interoperable electronic medical records system, thus reducing the burden on pharmacists. The West Virginia HB 4524 bill also requires that the pharmacy or pharmacist retains a record of the substitution for a period of at least two years.
The AAM 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’.
Staff from the American Cancer Society’s Cancer Action Network (ACS CAN) testified in support of the South Dakota bill and also worked to educate lawmakers ahead of committee action about the importance of affordable biological cancer treatment options. ACS CAN believes that ‘the bill in South Dakota will not only enhance patient access to new and potentially less costly medications, but also create an incentive for increased economic development by a biotechnology sector that has been rapidly growing in the state’.
Beyond South Dakota, ACS CAN has worked and continues to work in states across the country to advance policy change that incentivizes costs savings while maintaining safety and outcomes for patients.
Editor’s Comment
Readers interested to learn more about biosimilarity and interchangeability and state legislation 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
GaBI Journal is indexed in Embase, Scopus, Thomson Reuters’ ESCI, and more.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. 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 Apr 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. 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
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 Apr 13]. Available from: www.gabionline.net/Policies-Legislation/Compromise-reached-on-US-legislation-on-biosimilars-substitution
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Source: ACS CAN, LegiScan
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