Generic Biologic Drugs

(Generic Biologics; Biosimilars)

ByDaphne E. Smith Marsh, PharmD, BC-ADM, CDCES, University of Illinois at Chicago College of Pharmacy
Reviewed/Revised Apr 2023
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    Medications are drugs used therapeutically (that is, to treat medical conditions). Traditional drugs, such as antibiotics and blood pressure drugs, are called small-molecule agents because the active ingredient is usually a single, discrete chemical entity.

    Biologic drugs are complex products that are derived from biologic sources (human, animal, microorganisms, or yeast). Biologics include viruses, genes, blood and body tissues, antibodies, toxins or antitoxins, vaccines, and related products used for treating disease. Until now, it has not been possible to develop generic versions of these products because of their complex manufacturing requirements and the difficulty in defining their exact composition.

    Ongoing scientific developments may allow the creation of generic biologic products in the next several years. The advantage of generic biologic drugs for manufacturers, pharmacies, and consumers is that they could be freely interchanged and compete against one another for inclusion on a hospital or health plan drug list. Having different brands of very similar biologic products, as with epoetin, a hormone to increase red blood cell count, does not offer all the benefits of generically equivalent products.

    (See also Overview of Generic Drugs and Drug Naming.)

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