Industry May Like FDA's Biosimilar Guidance Withdrawal, But Not The New Information Vacuum
Sponsors may have to rely even more on the advice they receive from formal meetings as FDA decides to rewrite draft guidance on statistical approaches to evaluate analytical similarity for biosimilars.
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New draft guidance on statistical approaches eliminates previous recommendations on tiered ranking and statistical equivalence testing of product quality attributes, giving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.
US FDA asks for comments on whether the policy employed for small molecule generics also should apply to biosimilars.