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Biosimilars: US FDA Favors Quality Range Testing For Comparative Analytical Assessments

 
• By Sue Sutter

New draft guidance on statistical approaches eliminates previous recommendations on tiered ranking and statistical equivalence testing of product quality attributes, giving biosimilar sponsors more flexibility.

Close Up of bunch of identical sharp graphite pencils. Studio shot. Concept of uniformity. Concept of similarity. - Image
New guidance reflects the US FDA's current thinking on statistical analyses methods for demonstrating biosimilarity. • Source: Shutterstock

The US Food and Drug Administration has dialed back its recommendations on statistical approaches to comparative analytical assessments in a move aimed at giving biosimilar sponsors more flexibility.

A new draft guidance released on 21 May describes the use of quality range testing in lieu of statistical...

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