TUM Library

Includes bibliographical references and index.

Introduction -- Background -- Past Experience for In Vitro Bioequivalence Testing -- Analytical Similarity Assessment -- Scientific Factors and practical issues -- Aim and Scope of the Book -- Regulatory Approval Pathway of Biosimilar Products -- Introduction -- Regulatory requirements -- Analytical Studies for Functional/Structural Characterization -- Global harmonization -- Concluding remarks -- CMC Requirements -- Introduction -- CMC Development -- Manufacturing Process Validation -- Quality Control and Assurance -- Stability Analysis -- Concluding Remarks -- Assay Development and Process Validation -- Introduction -- Regulatory Requirements -- Analytical Method Validation -- Analysis of Validation Data -- Evaluation of Reliability, Repeatability, and Reproducibility -- Concluding remarks -- Critical Quality Attributes -- Introduction -- Identification of CQAs -- Classification of CQAs -- Concluding Remarks -- FDA Tiered Approach for Analytical Assessment -- Background -- Stepwise Approach -- Tier Equivalence Test -- Other tiered approaches -- Some Practical Considerations -- Concluding Remarks -- Sample Size Requirement -- Introduction -- Traditional Approach -- FDAs Current Thinking and Recommendation -- Sample Size Requirement -- Numerical Studies -- Concluding remarks -- Multiple References -- Background -- Method of Pairwise Comparisons -- Simultaneous Confidence Interval -- Reference Product Change -- Concluding remarks -- Extrapolation Across Indications -- Introduction -- An Example -- Development of Sensitivity Index -- Assessment of Sensitivity Index -- Statistical Inference of Extrapolation -- Concluding Remarks -- Case Studies - FDA Submissions -- FDA Abbreviated Licensure Pathway -- Sponsors Strategy for Regulatory Submission -- Avastin Biosimilar Regulatory Submission -- Herceptin Biosimilar Regulatory Submission -- Concluding Remarks -- --Practical and Challenging Issues -- Introduction -- Hypotheses versus Confidence Interval Approach -- Totality-of-the-evidence -- Inconsistencies Between Tired Approaches -- Individual bioequivalence -- Commonly Asked Questions from the Sponsors -- Concluding Remarks -- Recent Development-- -- Introduction -- Comparing Means versus Comparing Variances -- Switching Design -- Non-Medical Switching -- FDA guidance on Analytical Similarity Assessment -- Concluding Remarks.

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.

Also available in print format.