Difference Between Biosimilars and Reference Product

EP: 1.What are Biologics and Biosimilars, and How Are They Devolved?

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EP: 2.Difference Between Biosimilars and Reference Product

EP: 3.Differences Between Biosimilars and Generic Drugs

EP: 4.Defining Key Terms Associated With Biosimilars

EP: 5.Defining Extrapolation

EP: 6.Defining Interchangeability Status

EP: 7.Unmet Needs With Biosimilars

EP: 8.Impact of Biosimilars on Payers, Health Care System, and Patients

EP: 9.Role of Biosimilars and Assessing Clinical Impact

EP: 10.How to Switch Patients to Biosimilars

EP: 11.Challenges With Biosimilars Being Approved in the US

EP: 12.Clinician Confidence in Biosimilars

EP: 13.Addressing Patients' Concerns With Biosimilars

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