Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?

ABSTRACT

The status of insulins in the USA is about to change as a regulatory matter. After 23 Mar 2020 they, and other hormone products previously regulated as drugs by the US Food and Drug Administration (FDA), even though biologics in science, will become biologics as a regulatory matter too and will be licensed under the Public Health Service Act. This has a number of ramifications for sponsors, patients, and their physicians.