Understanding how interchangeability could drive automatic substitution

In 2018, the FDA issued guidance on biosimilar interchangeability. It states that a product granted interchangeable designation is expected to produce the same clinical result as the reference product in any patient without impacting safety or efficacy. 11

  • To date, no biosimilar approved in the United States has been granted the interchangeable designation by the FDA 9
  • To receive an interchangeable designation, a biosimilar must meet additional standards beyond those that were required for its approval as a biosimilar 11
  • The FDA designation of interchangeability means the biologic product may be substituted without intervention of the prescribing provider. At the state level, automatic substitution laws and requirements for notifying physicians may vary 10,12
  • It is important for physicians and patients to be aware of their state regulations, since this may affect their treatment choices 12

Download our informational brochure.