Biosimilar Interchangeability: How To Design A Multiple-Switch Study
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.
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Norwegian single-transition study would not satisfy agency's requirements for demonstrating interchangeability but could boost patient confidence in general concept of switching between reference product and biosimilar.
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