ABSTRACT

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.

chapter 1|28 pages

Introduction

chapter 3|24 pages

CMC Requirements for Biological Products

chapter 4|28 pages

Analytical Method Validation

chapter 5|22 pages

Critical Quality Attributes

chapter 7|26 pages

Sample Size Requirement

chapter 9|26 pages

Extrapolation across Indications

chapter 11|24 pages

Practical and Challenging Issues

chapter 12|38 pages

Recent Development