IS THERE ANTIBODY OUT THERE: THE ROLE OF IMMUNOLOGY IN THE DEVELOPMENT AND SUCCESS OF SECOND-GENERATION BIOLOGICS AND BIOSIMILARS

Abstract

Biologics, the cutting-edge drugs that bombard your commercial breaks, comprised seven of the ten top-selling drugs in 2018, raking in $125 billion dollars for the pharmaceutical industry worldwide. With such a significant amount of money to be made, many important details regarding the history and development of biologics are not widely emphasized. As first-generation biologics continue to be used today, second-generation biologics build on these principles to create drugs that treat some of the most widespread diseases in society. In addition, the pharmacological success of current biologic treatments for some of the most difficult diseases to treat, such as rheumatoid arthritis, ankylosing spondylitis, and hepatitis C, point towards the biologic drug’s innovative mechanisms of action that employ immunological techniques to target the source of these diseases. With so much success in recent years, the production of biosimilars aim to cut into these profits and decrease the cost of biologics. These biosimilars are not without their own challenges, as they face scientific and legal hurdles during development and testing. This thesis examines the past, present, and future of biologics and biosimilars, with a focus on the immunological principles that have allowed for the rapid success of these unique drugs.