1. Pink Sheet

Biosimilar Interchangeability Switching Studies May Use Foreign Comparators, US FDA Says

 
• By Sue Sutter

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contexts, agency cautions; easing of the US comparator-only recommendation is one of several changes from the 2017 draft guidance that could make pursuing an interchangeability designation easier.

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Building a bridge between foreign and US reference products might be more difficult for showing interchangeability than biosimilarity. • Source: Shutterstock

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

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