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Activity Number: 673 - Clinical Trial Design- 8
Type: Contributed
Date/Time: Thursday, August 2, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #327206 Presentation
Title: On Sample Size Requirement for Analytical Similarity Assessment
Author(s): Victoria Chang* and Yi Zhao and Shein-Chung Chow
Companies: AbbVie and Statistics Collaborative and Food and Drug Administration
Keywords: Biosimilar; Sample Size Requirement; Stepwise Approach; Analytical Similarity; Equivalence Test; Equivalence Acceptance Criterion

For approval of biosimilar products, the US FDA recommends a stepwise approach for obtaining the totality-of-the-evidence for assessing biosimilarirty between a proposed biosimilar product and its corresponding innovative (reference) biologic product. The stepwise approach starts with the assessment of analytical similarity of critical quality attributes (CQAs) for structural/physicochemical and functional properties in the manufacturing process of biosimilar products. For Tier 1 CQAs that are most relevant to clinical outcomes, the FDA recommends an equivalence test be performed for similarity assessment based on an equivalence acceptance criterion (EAC). While performing the equivalence test, sample size is a critical component of the equivalence test. This presentation focuses on the discussion of the FDA's proposal: select an appropriate sample size by adjusting EAC margin and reference variability. This talk would also provide a thorough discussion on the FDA's proposal; sample size requirement under different scenarios are briefly described and a numerical study that compare sample size requirement under various combinations of study parameters is conducted.

Authors who are presenting talks have a * after their name.

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