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Biosimilars Statistical Guidance Reflects Early Development Approach

 
• By Sue Sutter

US FDA's long-awaited draft guidance on statistical approaches for analytical similarity testing appears to echo what agency has been telling biosimilar product sponsors in private about ranking and testing reference product attributes according to criticality.

Identical twins
Statistically, they are the same.

A new US FDA draft guidance on statistical approaches for analytical similarity testing of biosimilars addresses issues, such as the number of product lots tested and equivalence margins, that have arisen in some of the early application reviews.

On the whole, however, the guidance may not break much new ground, particularly for those biosimilar sponsors that have already had one-on-one discussions

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