Tiered Approach of Analytical Similarity Assessment: Statistical Methods

Authored by: Yi Tsong

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:


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For approval of a biosimilar drug product, the U.S. Food and Drug Administration recommends a stepwise approach for obtaining the totality of the evidence between the proposed biosimilar product and its corresponding innovative biological product be considered. The stepwise approach starts with the assessment of similarity in identified critical quality attributes, which are classified into three tiers depending upon their corresponding criticality or risk ranking relevant to clinical outcomes. Appropriate statistical tests (e.g., equivalence test, quality range approach, and raw data graphical presentation) are then applied to these critical quality attributes in different tiers (e.g., Tier 1, Tier 2, and Tier 3, respectively). This article intends to provide an overview of these statistical tests for analytical similarity assessment in biosimilar studies.

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