Analytical Similarity Assessment in Biosimilar Product Development: 1st Edition (Hardback) book cover

Analytical Similarity Assessment in Biosimilar Product Development

1st Edition

By Shein-Chung Chow

Chapman and Hall/CRC

340 pages

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pub: 2018-08-01
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This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.

Table of Contents

  1. Introduction
  2. Background

    Past Experience for In Vitro Bioequivalence Testing

    Analytical Similarity Assessment

    Scientific Factors and practical issues

    Aim and Scope of the Book

  3. Regulatory Approval Pathway of Biosimilar Products
  4. Introduction

    Regulatory requirements

    Analytical Studies for Functional/Structural Characterization

    Global harmonization

    Concluding remarks

  5. CMC Requirements
  6. Introduction

    CMC Development

    Manufacturing Process Validation

    Quality Control and Assurance

    Stability Analysis

    Concluding Remarks

  7. Assay Development and Process Validation
  8. Introduction

    Regulatory Requirements

    Analytical Method Validation

    Analysis of Validation Data

    Evaluation of Reliability, Repeatability, and Reproducibility

    Concluding remarks

  9. Critical Quality Attributes
  10. Introduction

    Identification of CQAs

    Classification of CQAs

    Concluding Remarks

  11. FDA Tiered Approach for Analytical Assessment
  12. Background

    Stepwise Approach

    Tier Equivalence Test

    Other tiered approaches

    Some Practical Considerations

    Concluding Remarks 

  13. Sample Size Requirement
  14. Introduction

    Traditional Approach

    FDA’s Current Thinking and Recommendation

    Sample Size Requirement

    Numerical Studies

    Concluding remarks

  15. Multiple References
  16. Background

    Method of Pairwise Comparisons

    Simultaneous Confidence Interval

    Reference Product Change

    Concluding remarks

  17. Extrapolation Across Indications
  18. Introduction

    An Example

    Development of Sensitivity Index

    Assessment of Sensitivity Index

    Statistical Inference of Extrapolation

    Concluding Remarks

  19. Case Studies - FDA Submissions
  20. FDA Abbreviated Licensure Pathway

    Sponsor’s Strategy for Regulatory Submission

    Avastin Biosimilar Regulatory Submission

    Herceptin Biosimilar Regulatory Submission

    Concluding Remarks

  21. Practical and Challenging Issues
  22. Introduction

    Hypotheses versus Confidence Interval Approach


    Inconsistencies Between Tired Approaches

    Individual bioequivalence

    Commonly Asked Questions from the Sponsors

    Concluding Remarks

  23. Recent Development


Comparing Means versus Comparing Variances

Switching Design

Non-Medical Switching

FDA guidance on Analytical Similarity Assessment

Concluding Remarks

About the Author


Shein-Chung Chow, Ph.D, is currently an Associate Director at Office of

Biostatistics, Center for Drug Evaluation and Research, United States Food

and Drug Administration (FDA). Prior to joining FDA, Dr. Chow was a

Professor at Duke University School of Medicine, Durham, NC. He was

also a special government employee (SGE) appointed by the FDA as an

Advisory Committee member and statistical advisor to the FDA. Prior to

that, Dr. Chow also held various positions in the pharmaceutical industry

such as Vice President at Millennium, Cambridge, MA, Executive Director at

Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers

Squibb, Plainsboro, NJ. Dr. Chow is the Editor-in-Chief of the Journal of

Biopharmaceutical Statistics and the Editor-in-Chief of the Biostatistics Book Series

at Chapman and Hall/CRC Press, Taylor & Francis Group. He was elected

Fellow of the American Statistical Association and an elected member of the

ISI (International Statistical Institute). Dr. Chow is the author or co-author of

over 300 methodology papers and 29 books including Designs and Analysis

of Bioavailability and Bioequivalence Studies, Sample Size Calculations in Clinical

Research, Adaptive Design Methods in Clinical Trials, Translational Medicine,

Design and Analysis of Clinical Trials, and Quantitative Methods for Traditional

Chinese Medicine Development.

Subject Categories

BISAC Subject Codes/Headings:
MATHEMATICS / Probability & Statistics / General
MEDICAL / Pharmacology
MEDICAL / Biostatistics