What Is a Biologic?

Biologic

A biologic—or biologic product—is a medicine made from or by living cells, typically through a series of complex processing steps. The Public Health Service Act defines a “biological product” as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or another trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.” (42 U.S.C. § 262(i).)

Biologics may comprise sugars, proteins, nucleic acids, alone or in combination. Additionally, biologics may be composed of living materials, such as genetically engineered cells or tissues. Generally, biologics are used to diagnose, treat, or prevent various diseases, including cancer, diabetes, and cardiovascular disease, as well as autoimmune disorders like rheumatoid arthritis and inflammatory bowel disease.