How do biologic products differ from a conventional drug?

Answer

In contrast to most drugs that are chemically synthesized and their structure is known, biologics are derived from living sources, such as humans, animals, plants and microorganisms. Therefore, the HHS Food and Drug Administration (FDA) is responsible for regulating products as diverse as blood, blood components and their derivatives, allergenics, vaccines, biotechnology derived products such as monoclonal antibodies and cytokines and growth factors, and somatic cell and gene therapy.

Most biologics are complex mixtures that are not easily identified or characterized; they include those manufactured by biotechnology and tend to be heat sensitive and susceptible to microbial contamination.

Last Reviewed: 04/23/2008