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EU-approved comparator in the switch study for its biosimilar Erelzi, might have to redo the trial in light of FDA’s draft guidance.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EU-approved comparator in the switch study for its biosimilar Erelzi, might have to redo the trial in light of FDA’s draft guidance.