Event Summary:
A one-day workshop organized by the Center for Interdisciplinary Research and
Consulting at the University of Maryland, Baltimore County (UMBC), and the
Center for Innovative Study Design (CISD) at Stanford University in the field of Clinical Trials and Regulatory Science.
Registration is now closed
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Organizing Committee:
Faculty from UMBC and Stanford University and leaders from FDA and industry.
For more information:
Please contact Dr. Yi Huang, Department of Mathematics and
Statistics, University of Maryland Baltimore County (UMBC),
1000 Hilltop Circle, Baltimore, MD 21250.
E-Mail: yihuang@umbc.edu.
For any Technical difficulties Please contact Zana Coulibaly at czana1@umbc.edu.
Participant Information
Yi Tsong from CDER/FDA.
Paper: Development of equivalence test for the assessment of analytical biosimilarity
: To evaluate the analytical similarity between the proposed biosimilar product and the US-licensed reference product, a working group at Food and Drug Administration (FDA) developed a three-tier approach. This proposed tiered approach starts with a criticality determination of quality attributes (QAs) based on risk ranking of their potential impact on product quality and the clinical outcomes. Those QAs characterize biological products in terms of structural, physico-chemical, and functional properties. On the other hand, we propose three tiers of statistical approaches based on its levels of stringent in requirements. The three tiers of statistical approaches will be applied to QAs based on the criticality ranking and other factors. In this article, we discuss the statistical methods applicable to the three tiers of QA. We further provide more details for the proposed equivalence test as the tier 1 approach. We also provide some discussion on the statistical challenges of the proposed equivalence test in the context of analytical similarity assessment.