But scientific bridging required for non-US reference products might be more extensive than in other contexts, agency cautions; easing of the US comparator-only recommendation is one of several changes from the 2017 draft guidance that could make pursuing an interchangeability designation easier.
The US Food and Drug Administration has opened the door to use of foreign reference products in interchangeability switching studies but suggests the extent of scientific bridging data justifying this approach might go beyond what is needed in the biosimilar context.
In its long-awaited final