Interchangeability

BPC applauds FDA for establishing interchangeability standards through their draft guidance. When this guidance is final, FDA’s policy will provide important scientific information for manufacturers to consider when seeking licensure for proposed interchangeable products. BPC believes data required to demonstrate biosimilarity should be robust and risk-based to build prescriber confidence in this new class of medicine. Such confidence is particularly important for interchangeable biosimilars as these products may be substituted for the reference product without intervention from the prescribing healthcare provider. BPC believes applicants seeking FDA approval of a biosimilar as interchangeable should submit an application and justification for all of the reference product’s conditions of use. Additional perspective on this issue provided in our related material.