ABSTRACT
Though employed in traditional medicine over the millennia, biologics, as
we know them today, may trace their evolution to the scientific and social
developments of the late-19th and early 20th centuries. It was at this time that
novel discoveries in the fields of immunology-such as those of Koch and Pasteur-
and epidemiology combined with increased interest in public health to support
campaigns focused on the elimination of certain infectious diseases. As has
often been the case in the history of drug development, it was a tragedy that
highlighted an incomplete understanding of the science and technology employed,
and the subsequent need for regulatory oversight, in this case over biologics. In
this chapter, we will review the FDA’s (Food and Drug Administration) oversight
of biologics, identify similarities and differences to small molecule drugs as these
relate to their development and licensure, and provide an overview of the regulatory
processes that govern their entry to the market.
