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Biosimilars and the Issue of Interchangeability

Dr. Ellen M. Field, MD, a privately practicing rheumatologist in Lehigh Valley, PA, talks about the FDA 2017 guidance that advised manufacturers looking to obtain a designation for a biosimilar. Those seeking this designation have additional standards to meet than those needed for initial FDA approval as a biosimilar. To be interchangeable, biosimilar products must be able to be substituted by a pharmacist without an intervention from a health care provider prescribing the reference product. Dr. Field also noted that the FDA designation of interchangeability given to biosimilars is unique, and the rules for how substitution occurs and the requirements for notifying providers varies from state to state.