Biosimilar Sponsors Seek Statistical Flexibility When Reference Products Change
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of, changes in the reference product's quality attributes over time, biosimilar industry says in comments on US FDA's draft guidance on statistical approaches to analytical similarity; companies seek more flexibility on statistical testing methods and on source and number of products lots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.
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New draft guidance on statistical approaches eliminates previous recommendations on tiered ranking and statistical equivalence testing of product quality attributes, giving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.
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