Biosimilars: US FDA Favors Quality Range Testing For Comparative Analytical Assessments
New draft guidance on statistical approaches eliminates previous recommendations on tiered ranking and statistical equivalence testing of product quality attributes, giving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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Companies generally support decision not to require statistical equivalence testing but challenge agency’s skepticism about combining data from US and foreign reference products to set analytical similarity acceptance criteria.
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contexts, agency cautions; easing of the US comparator-only recommendation is one of several changes from the 2017 draft guidance that could make pursuing an interchangeability designation easier.
Sponsors may have to rely even more on the advice they receive from formal meetings as FDA decides to rewrite draft guidance on statistical approaches to evaluate analytical similarity for biosimilars.