Glossary Term


The meaning of “biologic” is a subject that comes with some debate. Generally, biologics are large, complex molecules that are usually produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, Other definitions broaden the category to include medications that have one (or more) organic substance as part of its composition. This latter criterion differentiates a biologic’s ingredients from a purely chemical composition associated with traditional drugs. The Food & Drug Administration (FDA), for its part, has recognized biologic medications as covering compositions that include “sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues.” Recombinant DNA is an element often associated with the production of biologics. This substance is created from DNA sections taken from multiple organisms, which are then combined to form a unique sequence and used to manufacture the proteins in the biologic.

Many biologics come have a high cost and it is common to find such drugs placed within the most expensive cost-sharing tier within a health plan formulary. The reasons behind expensive biologics are varied. Biologics are generally more difficult and expensive to bring through the approval process and more expensive to produce once approved than typical, small molecule drugs. In addition, the difficulty in getting competing drugs (biologics and biosimilars) approved often means there is a lack of competition to bring down prices for a longer period of time than normally seen with typical generic drugs.

Dependency on a living organism for the creation of a biologic results in a certain degree of variation among different batches of the same biologic medication. As is the case for other medications, biologics must be reviewed and approved by the Food & Drug Administration prior to their market use.

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