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Molly Billstein Leber, PharmD, BCPS, FASHP: Interchangeability Laws, Substitution, and the Future Role of Biosimilars


Molly Billstein Leber, PharmD, BCPS, FASHP: Looking at most states, most states do have some guidance on biosimilar interchangeability, and almost all of them say that you can only interchange if the FDA [US Food and Drug Administration] has declared the biosimilar products as interchangeable. To date, there are no interchangeable FDA-approved products, so the pharmacists are not allowed to convert between the different biosimilars on their own. I think a lot of health systems are creating [Pharmacy and Therapeutics Committee, P and T]—approved protocols or are picking 1 agent and only allowing that provider to order that within their [computer provider order entry, CPOE] system. Some states have gone down some sort of collaborative practice or [medication therapy management, MTM] route that then authorizes the pharmacist to be able to convert between the biosimilar or the originator to the biosimilar product through means other than the state legislation in collaboration with the providers at those organizations.

I think it’s important to know that they can’t automatically do it, currently. So, whatever the provider writes for is what the patient is going to get. If the provider, or if there is some sort of collaborative practice, or MTM, or any other process in place that allows the conversion between the biosimilar and the originator product, I think it’s very important that they understand that was a discussion among the physician leadership at the organization and that was a decision that was made after careful consideration. And since the biosimilar is highly similar to the biologic product, they should be comfortable in using either product, and that the choice being made is the most cost-effective and safe agent for that patient.

I want to say that one of my biggest passions is helping gain acceptance for biosimilars. I think that if we do not start using biosimilars, and if they do not start penetrating the market, we are in danger of not having them available to take care of our patients in the future. Biosimilars are very important as a cost-savings initiative as well as for increasing access to important drugs for our patients. So, we need to make sure that everyone’s on board and understands the advantages of biosimilars.

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