US-based healthcare services company Cardinal Health has launched an interactive map for interchangeable biosimilars as part of its information for biosimilars.
This announcement follows the landmark decision by the US Food and Drug Administration (FDA) to approve its first interchangeable biosimilar, Semglee (insulin glargine-yfgn), in July 2021 [1].
The laws on the interchangeability of biosimilars varies from state to state [2]. However, most of 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.
In addition, in most states, the pharmacist must provide notice to the patient and the prescriber ‘within a reasonable time’ and allow the use of an interoperable electronic medical records system, thus reducing the burden on pharmacists. This is in line with compromise automatic substitution language supported by brand-name and biosimilars makers and unveiled by the Association for Accessible Medicines in 2014 [3]. However, some state laws require communication within a certain number of days of dispensing the biosimilar and also require that the pharmacy or pharmacist retains a record of the substitution.
The interactive map launched by Cardinal Health aims to help users navigate their state’s specific guidelines and support patients with biosimilar adoption. It provides information on the specific laws for each state, including:
- the definition of interchangeability
- whether a pharmacist can automatically substitute an interchangeable biosimilar for the originator biological, without prior approval
- whether prescribers can prevent automatic substitution, e.g. by writing ‘dispense as written’ (DAW) or ‘brand medically necessary’
- whether pharmacists have to communicate the substitution back to the prescriber and/or patient, how this should be communicated and the timeline for such communication
- whether there is any legal immunity for pharmacists who make a substitution in compliance with biological state law
The map does, however, come with the caveat that the information is provided as a reference only and is not intended to be a comprehensive listing of all state laws or healthcare professional responsibilities.
Editor’s comment
Readers interested to learn more about interchangeability of biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Interchangeability. An insurmountable fifth hurdle?
Interchangeability of biosimilars in the US and around the world
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 10]. Available from: www.gabionline.net/es/biosimilares/novedades/fda-approves-first-interchangeable-insulin-glargine-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. 45 US states have passed biosimilar substitution laws [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 10]. Available from: www.gabionline.net/policies-legislation/45-US-states-have-passed-biosimilar-substitution-laws
3. GaBI Online - Generics and Biosimilars Initiative. Compromise reached on US legislation on biosimilars substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 10]. Available from: www.gabionline.net/Policies-Legislation/Compromise-reached-on-US-legislation-on-biosimilars-substitution
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