Differences Between Biosimilars and Generic Drugs

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

EP: 2.Difference Between Biosimilars and Reference Product

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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 are the key differences between a biosimilar and a generic small-molecule drug?

Joel M. Gelfand, MD, MSCE, FAAD: That’s a great question. It’s an important nuance. As clinicians, we’ve been used to generic drugs for quite some time. In dermatology, we use a medication called doxycycline for acne, which has other indications. Most of us don’t even think twice about what generic or brand originator is going to be dispensed to the patient. That’s largely because the molecule itself is truly identical, and what varies is maybe the excipients, or the color of the pill, or things of that nature. For the most part, as clinicians, you can usually get away with that with no problem whatsoever.

There may be some unusual circumstances where a patient has an allergy to one of the ingredients in the packaging of the generic medication, or maybe a rare circumstance where the PK [pharmacokinetics] may not be identical for a medication like cyclosporine. But biosimilars aren’t the identical product. They’re nearly identical, especially in the areas that matter the most in terms of where the biologic is binding the target—at the cytokine for example—but there can be some variation in protein structure, glycosylation, and other aspects of the antibody itself.

Roy M. Fleischmann, MD: That’s exactly right. A biosimilar isn’t exactly the same as a generic pill. There are differences between them.

Transcript Edited for Clarity