Difference Between Biosimilars and Reference Product

Drs Roy M. Fleischmann and Joel M. Gelfand discuss differences between biosimilars and reference products.

Roy M. Fleischmann, MD: What’s the difference between a biosimilar and a reference product?

Joel M. Gelfand, MD, MSCE, FAAD: They are just that. The reference product is usually the originator biologic, the one that did large-scale pivotal trials, often placebo-controlled or active comparator studies, competitor studies, or some type of standard of care. We’ve been using a lot of these molecules for decades. For example, etanercept and infliximab were approved in the late 1990s. Then the biosimilar product is a manufactured biologic process that, as you mentioned, doesn’t differ chemically or structurally in any important ways from the originator product, and then clinically has demonstrated very similar safety and efficacy.

Roy M. Fleischmann, MD: The only thing I’ll add is that I’d emphasize the point that the active part of the molecule of the biosimilar and the reference product are exactly the same. There may be a difference in folding. There may be a difference in glycosylation. That’s like the difference with a generic drug. A generic drug is a small-molecule chemical. It’s very easy to manufacture, and it’s identical to the brand product. The difference may be the excipients, or it may be a red pill vs a blue pill, but they’re exactly the same inside. It’s the same thing with the reference product and the biosimilar. The active moiety of the molecule is exactly the same, though there may be differences in things like folding and glycosylation.

Transcript Edited for Clarity

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