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Dr Gary Lyman: Are Interchangeability Designations for Biosimilars Meaningful?


Gary Lyman, MD, MPH, an oncologist and hematologist, explains that biosimilar substitution in the absence of interchangeability designations is widespread and not without clinical merit.

Gary Lyman, MD, MPH, is an oncologist, hematologist, and public health researcher who has long been an advocate for biosimilars. He has also developed guidelines in support of using biosimilars in the oncology space.


Is the interchangeable designation actually meaningful and necessary?

Lyman: So, as I often mention, the United States is the only country that has a designation of interchangeability. Globally, this would have very little impact in meaning. I think the reason is that interchanging [of these agents] is driven by the originator's safety and efficacy data and acceptance by the professional oncology organizations. Just showing that you can switch from one to the other, once you've already said that the agent is safe and effective as the originator, I think there's been very little question raised. There still is a little bit of hesitancy, in general, about changing products in the middle of a course of treatment. So, if a patient has started adjuvant therapy with a biosimilar and has been told that they have to use a different one to complete their therapy, it just doesn't sit real well with clinicians. Why should they be forced to switch a product that seems to be working fine and the patient is tolerating well just because it's a little less expensive or they're being told [to do so] by their institution?

So, there is some pushback, and with regard to that, but in general, interchanging of these agents is already taking place. No biosimilar has been removed from the marketplace, either in Europe or in the United States, even globally, that I'm aware of, because of concerns over adverse events or loss of efficacy by changing from one agent to the other. So, and as I've said, many times, even the reference product that we prescribe of a biologic, the originator drug, is not the same drug today as it was 20 years ago. So, it's, in a sense, a biosimilar of itself sitting on the shelf right now. Saying that we can't switch or shouldn't switch because of cost or regional concerns just doesn't hold up very strongly in my mind. I think that pushback on this issue, while I understand it and the gut feeling of why change? When something's working don't fix it. I'm not concerned about the safety and efficacy of doing that.

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