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In the draft guidance, "Considerations in Demonstrating Interchangeability With a Reference Product: Update," the agency has set out a change to its previously stated position that switching studies would generally be needed to demonstrate that a biosimilar could be considered interchangeable
Key Takeaways
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FDA is formally moving away from the general requirement for switching studies to support interchangeability.
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Agency attributes the change to its growing experience in evaluating potential analytical differences between products and advancements in analytical technologies