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Cate Lockhart, PharmD, PhD: Similarities Between Biosimilars and Generics


Cate Lockhart, PharmD, PhD, explains the similarities and differences between generics and biosimilars.


What are some ways in which biosimilars are like generics?

That’s true they’re not generics, but I think what people fail to realize or fully appreciate is that “no clinically relevant” difference. So, my PhD is in pharmaceutics so from a pharmacokinetics stand point a biologic— the innovator biologic– has quite a lot of variation within a single batch from lot to lot. But there’s really– you can keep taking that same innovator biologic, even though it’s going to be a little different than the last dose that you had, probably, or there’s a risk or chance there would be some level of variation. It’s probably not a lot of variation, but it is there, and you don’t see a clinically different response.

It’s the same story with biosimilars. There’s going to be variation, there’s going to be variation within the biosimilar lot. There’s going to be variation between it and the reference product to some extent within the threshold, but the exact same thing is true with generic drugs. There’s less variability within a lot in generic drugs, but the variation between the original branded small molecule drug and the generic is still within the threshold. So, it’s not identical ultimately, [but] there is a threshold and it’s really the same story with biologics that there’s variation anyway, but it doesn’t manifest itself in any clinically relevant way.

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