Biological products, or biologics, are a diverse group of treatments that include allergenics, vaccines, growth factors, immune modulators, recombinant therapeutic proteins, and gene therapy. These biologics may comprise of sugars, proteins, nucleic acids, or intricate combinations thereof derived through biotechnological processes from sources like blood, cells, and tissues of living organisms. It is important to note that biologics are often sensitive to heat and susceptible to microbial contamination.
Examples of biologics include blood and blood products for transfusion, the COVID-19 mRNA vaccine, and cell and gene therapy products used for cancer treatments (e.g., ABECMA, ADSTILADRIN).
Most biologics fall under the regulation of the Center for Biologics Evaluation and Research (CBER). To request permission for interstate commerce introduction or delivery of a biological product, a Biologics License Application (BLA) must be submitted.
The Purple Book Database contains information on all FDA-licensed (approved) biological products overseen by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products alongside their reference products. It also includes data on all FDA-licensed allergenic, hematologic, vaccine, and cellular/ gene therapy products regulated by the Center for Biologics Evaluation and Research (CBER).