Nonbiologic

Nonbiologic is an adjective describing something that is not derived from living organisms or biological processes. In science and medicine, it is used to distinguish substances, products, or materials that originate from chemical synthesis or inorganic processes from those that are biologically produced or derived from living systems. The term is commonly applied to medicines and therapies: nonbiologic drugs are typically chemically synthesized small molecules, contrasted with biologics such as monoclonal antibodies, vaccines, or cell therapies, which are produced by living systems.

In regulatory contexts, nonbiologic drugs are usually regulated under pathways designed for chemically synthesized compounds, whereas biologics require separate frameworks due to their complexity, manufacturing nuances, and potential immunogenicity. There is also a related concept of nonbiologic complex drugs (NBCDs) in some jurisdictions, referring to products that are not strictly small molecules but have complex chemical or physical properties that are not fully characterized by standard chemistry alone.

Beyond medicine, nonbiologic can describe materials and technologies not derived from biology, such as metals, polymers, ceramics, and many conventional medical devices. The term is largely descriptive rather than taxonomic, intended to facilitate comparisons between living-derived and non-living-origin substances.

See also: biology, biologic, biosimilar, small molecule, biotechnology.