Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also a professor of clinical sciences at Duke–National University of Singapore Graduate Medical School. He is the editor-in-chief of the Journal of Biopharmaceutical Statistics and editor-in-chief of the Chapman & Hall/CRC Biostatistics Series. He has authored or co-authored over 230 papers and 22 books, including Adaptive Design Methods in Clinical Trials, Second Edition, Handbook of Adaptive Designs in Pharmaceutical and Clinical Development, and Controversial Statistical Issues in Clinical Trials. A fellow of the ASA and member of the ISI, Dr. Chow has received the ASA Chapter Service Recognition Award, the DIA Outstanding Service Award, and the ICSA Extraordinary Achievement Award.

• Introduction. Bioequivalence Experience for Small-Molecule Drug Products. Regulatory Requirement for Assessing Follow-On Biologics. Criteria for Similarity. Statistical Methods for Assessing Average Biosimilarity. General Approach for Assessing Biosimilarity. Non-Inferiority versus Equivalence/Similarity. Statistical Test for Biosimilarity in Variability. Sample Size for Comparing Variabilities. Impact of Variability on Biosimilarity Limits for Assessing Follow-On Biologics. Drug Interchangeability. Issues on Immunogenicity Studies. CMC Requirements for Biological Products. Test for Comparability in Manufacturing Process. Stability Analysis of Biosimilar Products. Assessing Biosimilarity Using Biomarker Data. Current Issues in Biosimilar Studies. References. Index.

"This book extensively covers both statistical and regulatory considerations from design to analysis of biosimilarity. ... it is well presented and comprehensively covers fundamental issues and some of the newly developed methods for biosimilarity studies. The book is very balanced between scientific aspects and regulatory requirements. In addition, the reference lists give readers helpful information. ... a valuable resource for anyone interested and involved in biosimilarity studies." -Biometrics, September 2014 "[Professor] Chow's book Biosimilars: Design and Analysis of Follow-On Biologics ... is the first book ever written on this topic. I commend Professor Chow for his effort to introduce the topic ... Overall, this is a worthwhile reference book for statisticians interested in understanding biosimilar product development and evaluation." -Yi Tsong, PhD, Center for Drug Evaluation and Research, US Food and Drug Administration, USA, in Journal of Biopharmaceutical Statistics