Biosimilars and the Issue of Interchangeability

June 2018

Rheumatologist Dr. Ellen Field outlines the FDA's draft guidance on biosimilar interchangeability.

In 2017, the FDA issued draft guidance on biosimilar interchangeability stating that an interchangeable product is expected to produce the same clinical result as the reference product in any patient. In other words, the biosimilar and its reference product can be switched without impacting safety or efficacy. Dr.Ellen Field explains more, including the processes of substitution and switching, and the roles of physicians and pharmacists in each. Visit for more info.
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