ABSTRACT
Biological laws and regulations have been promulgated over 140 years from 1883 to 2019 to protect the health and well-being of society. This chapter focuses on the laws and regulations from the US government and, especially, the US Food and Drug Administration (FDA) that control and guide the industry and the use of drugs and, especially, biologicals. The “totality of the evidence” is reviewed by FDA, and a streamlined regulatory application for approval is possible with extra emphasis on the chemistry and characterization of the new biosimilar molecule compared to the reference standard and less clinical trials. For product approvals, a company must establish the triumvirate of efficacy, safety and quality for a drug, biological, or device in the applications for approval at the FDA and the European Medicines Agency. To accelerate approval of products and improve availability of therapies for patients, the federal government has empowered the FDA with a series of accelerated product approval processes.
