COMMENTARY

Sorting Through the Confusion of Biologic Drug Names

Gayle Nicholas Scott, PharmD

Disclosures

August 19, 2016

In This Article

Biologics: Broadly Defined

"Biological therapy" is a nonspecific term and goes by other names—including a biologic, biological drug/agent, biopharmaceutical, immunologic drug/agent, immunomodulator, biological response modifier, and targeted treatment, among others. To increase complication further, biological drugs are inconsistently grouped according to their molecular size and structure, mechanism of action, or physiologic effect—and the resulting names of the drugs border on the unpronounceable.

Strictly defined, a biologic is a treatment derived from an organic source. In this sense, vaccines for smallpox and rabies and antitoxins for diphtheria and tetanus, which were introduced in the 19th century, were among the first biologics.[1]

The more contemporary connotation of the term "biologics" is drugs produced by biotechnology, often using recombinant DNA methods. The first recombinant medicine was biosynthetic "human" insulin (Humulin®) in 1982. Since then, the US Food and Drug Administration (FDA) has approved more than 100 recombinant-protein based drugs.[2] Of the 45 drugs approved by the FDA in 2015, 14 end in -mab, -mib, or -nib.[3]

Biologics that are derived from microorganisms, plant cells, or animal cells are very large molecules that are often produced by DNA technology (eg, monoclonal antibodies). So-called "small molecules" are chemically synthesized drugs that act intracellularly (eg, sorafenib and bortezomib). "Small molecule" may also refer to a majority of more conventional drugs, such as penicillin and hydrochlorothiazide.[4]

The process for naming biologics, whether large or small molecule, is covered in a 53-page document produced by the World Health Organization, as well as an American Medical Association website reporting on the United States Adopted Names specifications for naming biologics and related compounds.[5,6] These multisyllabic names are often tongue-twisters that can perplex even the most medicinally fluent clinician. What follows is a guide to deciphering and pronouncing some of them.

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