Interchangeability: FDA Sets ‘Stringent’ Standard On Design Differences
Sponsors must assess any differences in a biosimilar’s container closure system or delivery device relative to the US reference product and may need to conduct comparative use human factor studies to ensure there is no increased risk of use-related error with the biosimilar.
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Sandoz, which used an EU-approved comparator in the switch study for its biosimilar Erelzi, might have to redo the trial in light of FDA’s draft guidance.
US FDA guidance lays out two types of study design recommendations: a dedicated study to demonstrate interchangeability, and an integrated study intended to support determinations of both biosimilarity and interchangeability.
US FDA sees role for postmarketing data to help address residual uncertainties and determine additional data needs, but not as basis for securing an interchangeability designation absent a clinical, multi-switching study, draft guidance states.