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FDA Heralds The End Of Switching Studies For Biosimilar Interchangeability

Guidance Suggests Analytical And Clinical Data Can Be Sufficient To Support Application

 
• By Dave Wallace

New guidance published by the US FDA suggests that switching studies will no longer be expected as standard to support determinations of biosimilar interchangeability, with the agency instead suggesting that analytical and clinical data will suffice.

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

Fresh guidance published by the US 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.

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