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Make Interchangeability Great Again: Biosimilar Switching Studies Need US Comparators

 
• By Sue Sutter

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an EU-approved comparator in the switch study for its biosimilar Erelzi, might have to redo the trial in light of FDA’s draft guidance.

FDA is drawing a clear line between clinical studies intended to support biosimilarity versus those aimed at demonstrating interchangeability when it comes to the source of the comparator reference product.

Sponsors pursuing interchangeability determinations should use a US-licensed reference product in switching studies examining the effects of multiple transitions between the biosimilar and innovator product, the agency’s draft...

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