The latest state to enact a law that allows the substitution of biosimilars at the pharmacy level is South Dakota. The signing of the bill marks the first biologicals substitution bill in 2018 to be signed into law.
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].
In South Dakota, Governor Dennis Daugaard signed Senate Bill 75 into law on 8 February 2018. The South Dakota House of Representatives passed the bill at the end of January with a vote of 68−0. This was preceded by a vote of 34−0 on the same bill in the Senate earlier in January.
The South Dakota 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 ‘brand necessary, or words of similar meaning’ 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 SB 75 bill differs 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 GPhA. The bill, however, does allow the use of an interoperable electronic medical records system, electronic prescribing technology or pharmacist benefit management system, thus reducing the burden on pharmacists.
The Biotechnology Innovation Organization (BIO) voiced its approval for the passing of the law. BIO says that it has ‘made significant progress advancing this important priority in the early weeks of this year’ and adds that it will ‘keep up the pressure until all 50 states enact this important public policy’.
South Dakota is the 37th state, plus Puerto Rico to enact biologicals substitution laws. This means that almost 90% of the US population is now covered by such laws. Similar proposals are moving through the legislative process in both Michigan and Wisconsin. Biologicals substitution legislation is also pending in Alaska, New Hampshire, Vermont and Wyoming.
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
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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 May 18]. 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 May 18]. 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 May 18]. Available from: www.gabionline.net/Policies-Legislation/Compromise-reached-on-US-legislation-on-biosimilars-substitution
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