Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms), are not easily identified or characterized, and many are manufactured using biotechnology. CBER is the Center within FDA that regulates biological products for human use. The CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.[1]
It should be noted that biologics that are used as drugs (i.e. erythropoietin, insulin, therapeutic antibodies) are under the jurisdiction of the Center for Drug Evaluation and Research (CDER).[2] However, in these cases, the CBER is still responsible for approving the sponsors Biological License Application (BLA) allowing the manufacture of the biologic.
