ABSTRACT

The discovery of DNA in 1953, and the many advances made afterwards in cellular and molecular biology in the late 1970s brought into existence the biotechnology industry. Of particular importance was the development of recombinant DNA technology which enabled the creation and production of proteins in a laboratory setting. These technological advances have provided biopharmaceutical companies with the tools needed to develop “targeted therapies” aimed at the biological underpinnings of various diseases. The first recombinant biologic therapy licensed in the United States (U.S.) was recombinant human insulin which was approved by U.S. Food and Drug Administration (FDA) in 1982. Since the approval of recombinant human insulin, more than 200 biological products have been approved over the past several decades, treating diseases ranging from cancers to rare genetic disorders (Guilford-Blake and Strickland (2008)). As of 2013, more than 900 molecules, targeting over 100 diseases including cancer, multiple sclerosis, and rheumatoid arthritis, were at various stages of development (PhRMA (2013)). These biotechnology-derived therapeutics hold a great deal of promise for future medicinal innovation and breakthroughs.