Biologic drugs are derived from living organisms or contain components of living organisms. This category includes vaccines, blood components, gene therapies, and monoclonal antibodies.
Composition:
These drugs are typically large and complex molecules or mixtures, such as proteins and nucleic acids, which are not easily characterized.
Regulation:
In the United States, biologic drugs are regulated by the Food and Drug Administration (FDA) under the Public Health Service Act, requiring a Biologics License Application (BLA).
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