Introduction
The Office of Biotechnology Products in FDA's Center for Drug Evaluation and Research (CDER) conducts quality reviews of biologics.
Biological products are defined as a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or analogous product applicable to the prevention, treatment or cure of a human disease or condition.
CDER's Office of Biotechnology Products regulates analogous biological products. A product is an analogous biological product if it is composed of some organic constituent of whole blood or plasma other than a hormone or an amino acid. For example, antibodies are an organic constituent of whole blood or plasma. So the CDER Office of Biotechnology Products regulates monoclonal antibodies as they are analogous to antibodies present in serum.
