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Generic Biologic Drugs

by Harold M. Silverman, PharmD

Traditional drugs are called small-molecule agents because the active ingredient is usually a single, discrete chemical entity. Biologic drugs are complex products that can be derived from viruses, blood and body tissues, antibodies, toxins and 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. Companies have made several attempts to get approval for generic equivalent biological products, such as human growth hormone. However, the Food and Drug Administration has required manufacturers of the proposed products to submit for approval under new drug regulations rather than as a generic equivalent. 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.