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Defining Unbranded Biologics


Distinctions between unbranded biologics, branded biologics, and biosimilars are explored by David Charles, MD.

David Charles, MD: For those of you who have been thinking about biologics and biosimilars, those 2 terms may be relatively common to you. But a new term that is commonly used is unbranded biologic. For example, a manufacturer has a branded biologic. It’s FDA approved and available, and it has its BLA [Biologics License Application] name, the biologic license name. Equate that to, for lack of a better term, the generic name of the medication, but it isn’t exactly generic. It’s the BLA name.

There’s also the brand name. Those names are the ones you see on advertisements for the biologic. An unbranded biologic would be when the same manufacturer produces the exact same biologic and makes it available in the marketplace but only with the BLA name, its nonproprietary name, and not the brand name of the medication. At the end of the day, the unbranded biologic and originator biologic are the exact same medication.

When thinking about the originator biologic, a biosimilar, and an unbranded biologic, how are those the same or different? Here’s how I think of it. An originator biologic is the original biologic that came to market. A biosimilar is exactly what the name sounds like. It’s a similar medication, often highly similar, but not exactly the same medication. It’s a little different. Then an unbranded biologic is the same medication made by the same manufacturer as the branded originator biologic. The unbranded biologic is the same product as the original.

To be sure, I’m not an expert in the regulatory requirements of biologics and biosimilars, but when we use the term unbranded biologic, we’re talking about the exact same medication made by the same manufacturer as the branded biologic, the originator biologic. In that case, they’re able to use all of the same labeling that’s used with the branded biologic because it’s the same medication. From the physician’s perspective or the patient’s perspective, it’s the same medication. The differences are the packaging and the labeling on the vial of medication and its boxes or containers when it’s shipped and transported.

As a physician, when I think of unbranded biologics and how they fit in to the overall availability of products to treat my patients, having more options available as a clinician is always better. If I have the originator biologic, biosimilars, and an unbranded biologic available, that’s more options for me. I’m not a businessperson, but I’d certainly hope that having more options available means more opportunity for cost savings to the patient and to our health care system.

Transcript edited for clarity.

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