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FDA Recommends Switching Studies to Demonstrate Biosimilar Interchangeability

January 23, 2017

Sponsors seeking approval for an interchangeable biosimilar should plan to conduct a switching study using a U.S.-licensed comparator product and primary endpoints that assess clinical pharmacokinetics (PK) and pharmacodynamics (PD).

In highly anticipated draft guidance, the agency said it generally expects sponsors to include data from a switching study for one or more of the reference product’s indications to support the demonstration of interchangeability. Sponsors should select an indication that would support subsequent extrapolation for other approved uses.

In addition to conducting switching studies, which are designed to evaluate the effect of alternating between use of a biosimilar and the reference product, sponsors can include the identification and analysis of critical quality attributes, mechanisms of action and differences between the products to support interchangeability.

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