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Evaluating Biosimilar Interchangeability


A glance at the process and regulations of switching, plus how an interchangeability study is conducted.

Timothy O’Shea, PharmD, MS [00:06:09] Interchangeability is something that's been there's been a lot of discussion on recently, particularly with the most recent MRA, biosimilars and so forth, in order in order for a biosimilar to be make its way to the market, first need to be approved by the FDA meeting the FDA's high standards of a biosimilar on the basis of there being no clinically meaningful differences For a biosimilar to also be deemed interchangeable, the manufacturer would have to conduct an additional study what's known as interchangeability study, also known as a switch study that would essentially look at how patients do when switched from an originator product to a biosimilar and vice versa. What's interesting is that of the 41 biosimilars that have currently been approved by the FDA, only four products have that interchange status. So it's a small number outside of just interchangeability. The ability for a pharmacist to substitute for a non interchangeable product is something that's going to vary depending on state law. So at this point, nearly all states, if not all, have some type of regulations on the book when it comes to substitution of a biosimilar. And the specifics will vary state by state. Most states allow pharmacists to substitute a biosimilar for a reference product without explicit approval from the provider. Typically, there's a notification process where the pharmacist will have to notify a patient and provider within some period of time. There are some states that do require a little bit more strict, that do require explicit approval from the provider and you know, the significance or the importance of a biosimilar having interchange status is something that I think will will vary depending on who you're talking to. But leading thought in the industry is that the standards of getting a biosimilar to market are so, so rigorous. These being highly similar products expected to have similar efficacy outcomes that additional interchange studies really are needed. That that's kind of the prevailing thought. And interestingly, when you look in Europe, for example, they've recently addressed the concept of interchange. And so after nearly 15 years of biosimilar experience, the EMA European Medicines Agency recently came out and said that change studies wouldn’t be needed in order for biosimilars to be considered interchangeable. So we're not quite there in the United States, but it's something to keep an eye on.

Transcript is AI-generated and edited for clarity and readability.

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