Biological products, or biologics, are a diverse group of treatments that include allergenics, vaccines, growth factors, immune modulators, recombinant therapeutic proteins, and gene therapy. Biologics can consist of sugars, proteins, nucleic acids, or a complex combination of the listed substances. These products, with the help of biotechnology, can be derived from various natural sources, including the blood, cells, and tissues of living organisms. It is important to note that biological products tend to be heat sensitive and susceptible to microbial contamination.
Most biologics are regulated by the Center for Biologics Evaluation and Research (CBER). To request permission for introduction or delivery for introduction of a biological product into interstate commerce, a Biologics License Application (BLA) must be submitted.
The Purple Book Database contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products and their reference products. The Purple Book includes knowledgeable material of all FDA-licensed allergenic, hematologic, vaccine, and cellular/ gene therapy products regulated by the Center for Biologics Evaluation and Research (CBER).