Interchangeability of Biosimilars


Ryan Haumschild, PharmD, MS, MBA: Another topic that’s is important for us to talk about is what is an interchangeable product? This is because many people are saying, “If you’re telling us that this compound is very similar, if it’s highly similar to the originator biologic product and meets all the FDA requirements, can I interchange?”

An interchangeable product is a biosimilar that meets additional requirements outlined by the Biologics Price Competition and Innovation Act. Part of fulfilling these additional requirements means that information is needed to show that a product is specifically interchangeable. It should produce the exact same clinical result as the reference product for any given patient. Also, for these products that are administered to more than 1 patient, we need to make sure the safety and efficacy of switching back-and-forth has been established, so interchangeable products may be substituted for the reference biologic product without involvement from the prescriber. That’s where it starts to get different because interchangeability status for biosimilar hasn’t been set; it’s something that we’re looking for. It’s something that’s going to be innovative. In the current state, we treat these as separate products, and we need the provider approval or some type of collaborative practice agreement or P&T [pharmacy and therapeutics] policy to switch out these products. This isn’t something that can be done independently without any prescriber input or any organizational policy put in place. So it’s important that we start on those fundamental building blocks, that biosimilar, highly similar focus on the manufacture process. I really want to get to a place where I can call it that interchangeability status.

Bhavesh Shah, RPh, BCOP: Thank you for that extensive summary and interpretation. It’s a great point to talk about interchangeability because there’s definitely this perception that interchangeability is this higher designation that a biosimilar has, right? Brandon or Tim, do you guys have any perspective? Does that actually matter to your practice in adopting a biosimilar based on its interchangeability status?

Brandon Dyson, PharmD, BCOP, BCPS: I can speak to my practice and community. I don’t think it would matter a whole lot. At this point, as we said, there is no interchangeable status for a biosimilar.

Bhavesh Shah, RPh, BCOP: For my other question, is that basically considered inferior to the reference product because you don’t have interchangeability status with any of the biosimilars?

Brandon Dyson, PharmD, BCOP, BCPS: I don’t think so. I don’t think it impacts our practice that way because there are data. The amount of data that’s required to get that interchangeable status is a lot. It also costs a lot. That’s why I would assume it’s not been done by anyone doing a biosimilar. If the biosimilar that’s not interchangeable is already in practice guidelines, and in many cases has the same FDA label, is there a huge incentive? We have a P&T committee, at least at my previous organization, that can determine if it’s worth it. But I don’t think it would make a huge difference, at least in my setting.

Tim Peterson, PharmD, BCOP: To bring it back with regard to a standalone cancer institute, it similarly does not have much of a bearing for our incorporation of biosimilars. Our incorporation of biosimilars, which I’m sure we’ll touch on later, in the hospital network setting, we’re essentially treating the biosimilar to its biologic reference product as “interchangeable” within our institution with pharmacy substitution anyway. Bhavesh can probably speak to this, but my understanding is similar to Brandon’s. I don’t believe any manufacturers have attempted this because it also seems like it curtails and defeats some of the purpose of the biosimilar process, which is to cut developmental costs. Then we’re going to proceed to this additional very likely financial-burdensome process.

Bhavesh Shah, RPh, BCOP: Sure. I absolutely agree. We don’t want to belabor this anymore. We established that it does not give it a higher designation, and I don’t think many manufacturers would be pursuing that because I don’t see a value into that.

Transcript edited for clarity.

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