Make Interchangeability Great Again: Biosimilar Switching Studies Need US Comparators
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an EU-approved comparator in the switch study for its biosimilar Erelzi, might have to redo the trial in light of FDA’s draft guidance.
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Using comparator biologics not licensed in the US is foreseen in final FDA interchangeability guidance, shifting the agency’s previous stance on biosimilars.
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.
Company's application development seems to be outpacing FDA's policy development in next step along the 351(k) pathway.