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Biosimilar Sponsors Seek Statistical Flexibility When Reference Products Change

 
• By Sue Sutter

Ability to design a statistical analysis plan is hampered by lack of control over, and even knowledge of, changes in the reference product's quality attributes over time, biosimilar industry says in comments on US FDA's draft guidance on statistical approaches to analytical similarity; companies seek more flexibility on statistical testing methods and on source and number of products lots for analytical comparisons.

The US FDA's draft guidance on statistical approaches for analytical similarity testing does not take sufficient account of biosimilar sponsors' lack of control over the reference product and runs the risk of overstating the role that statistics should play in establishing biosimilarity, industry representatives say.

In comments on the guidance, industry groups and individual companies also seek more flexibility from FDA on the statistical testing methods for Tier 1 attributes, the use of foreign reference

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