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Bethesda North Marriott Hotel and Conference Center

2016 年 04 月 25 日 1:00 下午 - 2016 年 04 月 27 日 4:30 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Statistics 2016 Forum

Now in its tenth year, the Forum fosters open discussion of timely topics of mutual theoretical and practical interest to biostatisticians and clinical trialists.

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Session 6: Analytical Similarity Assessment for Biosimilars

Session Chair(s)

Eric M. Chi, PhD

Executive Director

Amgen, United States

Yi Tsong, DrSc, PhD

Yi Tsong, DrSc, PhD

Director, Division of Biometrics VI, Office of Biostatistics, OTS, CDER

FDA, United States

Analytical similarity plays a fundamental role in the evaluation of biosimilar application. A tiered approach has been recommended by the FDA. The method to assess similarity for Tier 1 critical quality attributes (CQAs) is an equivalence test with the objective to show the mean difference between test (biosimilar) and reference products is within a pre-specified margin, and the method to assess similarity for Tier 2 CQAs is by a justified quality range. In consideration of small number of observations and for the comparisons to be uniform and objective, FDA recommends to use 1.5 as the equivalence margin and mean ± c as the quality range where c needs to be justified. They are so recommended such that the inferences could have sufficient power. In this session, experts from the FDA, industry and academia will share their experiences and research of issues related to assessing analytical similarity.

Speaker(s)

Yi Tsong, DrSc, PhD

Development of Equivalence Test for Analytical Similarity

Yi Tsong, DrSc, PhD

FDA, United States

Director, Division of Biometrics VI, Office of Biostatistics, OTS, CDER

Handling Heavily Unbalanced Sample Size of Analytical Similarity Equivalence Test

Cassie Dong, PhD

FDA, United States

Mathematical Statistician, Division of Biometrics VI, OTS, CDER

Issues of Correlated Values in Equivalence Test for Analytical Biosimilar

Meiyu Shen, PhD

FDA, United States

Expert Mathematical Statistician, Office of Translational Sciences, CDER

Richard O. Montes, PhD

Analytical Similarity Assessment: Practical Challenges and Statistical Perspectives

Richard O. Montes, PhD

Hospira, A Pfizer Company, United States

Associate Director, Statistics (Biosimilars Pharmaceutical Sciences)

Shein-Chung Chow, PhD

Discussant

Shein-Chung Chow, PhD

Duke University, United States

Professor, Department of Biostatistics and Bioinformatics, School of Medicine