ABSTRACT
Unfortunately, there is no precise definition that clearly delineates a biologic product from other drugs regulated by the FDA. The classification of a particular product as a “biologic” is the result of over 100 years of interaction between science and legislation. When viewed from today’s perspective, some of the resultant classifications seem inconsistent and even confusing (for example, all hormones are regulated as drugs and all vaccines are regulated as biologics-regardless of their method of manufacture).
