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Biosimilars: US FDA Heralds The End Of Switching Studies For Interchangeability

 
• By Dave Wallace

New guidance suggests that switching studies will no longer be expected as standard to support determinations of biosimilar interchangeability; instead, analytical and clinical data may suffice.

Red on off switch
The FDA is switching off the requirement for switching studies • Source: Shutterstock

Fresh guidance from the Food and Drug Administration has heralded yet another change for biosimilar interchangeability in the US, with the agency suggesting that analytical and clinical data will suffice to support a determination of interchangeability, rather than applicants needing to conduct separate switching studies.

In the draft guidance, "Considerations in Demonstrating Interchangeability With a Reference Product: Update," the agency has set out a...

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