Biologic & biosimilar interchangeability across the USA: state-specific legal requirements

The Interactive Map is a digital medical education tool designed to clearly and visually communicate key state laws for interchangeable biologics and biosimilars across the United States. Health care providers, health insurance providers and even patients can easily explore questions of interest by applying filters to the map and/or clicking on specific states to learn more.

Interchangeable or interchangeability means that the biological product may be substituted for the reference product without the intervention of the prescribing health care provider – 42 USC §262(k)(4)(A) (2010)
Substitution is the practice of exchanging one biologic product for another at the pharmacy level, without the intervention of the prescribing health care provider – FDA, Interchangeable Biological Products

For informational use only and does not provide legal advice. All the information provided herein is from publicly available sources.

All information is accurate as of December 2023.