The questions are, the guidance on the statistical approaches to analytical similarity is particularly important as it impacts initial improvability as a biosimilar under the 351K.
Bill Cassidy: “The questions are, the guidance on the statistical approaches to analytical similarity is particularly important as it…”
On the recordSeptember 16, 2015
Source
congress.govEditor's note · Context
Cassidy emphasizes the importance of guidance on statistical approaches for biosimilars.
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