Methodologies in Biosimilar Product Development

Sang Joon Lee, Ph.D., is a Senior Executive Vice President at Celltrion, inc. Dr. Lee was previously an assistant Professor at the University of New Mexico School of Medicine, and a Research Associate and Statistical Analyst at The University of Texas, M.D. Anderson Cancer Center. He received the B.S. degree in Statistics from Inha University, the M.S. degree in Statistics from the Seoul National University, and the Ph.D. degree in Statistics from Texas A&M University. Dr. Lee has authored or co-authored over 100 research papers and invited papers.Shein-Chung Chow, Ph.D., is a Professor at Duke University School of Medicine. Dr. Chow was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Executive Director at Covance, and Director and Department Head at Bristol-Myers Squibb. He received the B.S. degree in mathematics from East China Normal University, and the Ph.D. degree in Statistics from the University of Wisconsin-Madison. Dr. Chow has authored or co-authored over 310 methodology papers and 31 books.

• Preface. 1. Biosimilar Product Development. 2. CMC Consideration for Quality. 3. Quality by Design. 4. Stability Studies. 5. Two One-sided Tests Versus Confidence Interval Approach. 6. Equivalence Test with Flexible Margin. 7. mQR Method for Analytical Similarity Evaluation. 8. PK/PD Bridging Studies. 9. Clinical Strategy for Non-inferiority/Similarity Margin Selection. 10: Design and Analysis of Biosimilar Switching Studies. 11: Detection of Reference Product Change. 12. Sensitivity Analysis for Assessment of Extrapolation Across Indications. 13. Design and Analysis of Non-medical Switch. 14. Case Studies. References. Subject Index.