As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator’s biologic products. But scientific challenges remain due to the complexity of both the manufacturing process and the structures of biosimilar products.
Written by a top biostatistics researcher, Biosimilars: Design and Analysis of Follow-on Biologics is the first book entirely devoted to the statistical design and analysis of biosimilarity and interchangeability of biosimilar products. It includes comparability tests of important quality attributes at critical stages of the manufacturing processes of biologic products.
Connecting the pharmaceutical/biotechnology industry, government regulatory agencies, and academia, this state-of-the-art book focuses on the scientific factors and practical issues related to the design and analysis of biosimilar studies. It covers most of the statistical questions encountered in various study designs at different stages of research and development of biological products.
Table of Contents
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.
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.