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Biosimilar Interchangeability: NOR-SWITCH-Type Study Not Enough For US FDA

 
• By Sue Sutter

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.

The landmark NOR-SWITCH study may help bolster public confidence in biosimilars even though this type of study would not be enough to secure an interchangeability designation from the US FDA, experts said at a DIA biosimilars conference.

FDA does not consider a study akin to NOR-SWITCH, which involved a single transition from a reference product to a biosimilar, adequate to support an interchangeability determination, according to Leah...

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