ABSTRACT

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 manuf

chapter 1|26 pages

Introduction

chapter 4|24 pages

Criteria for Similarity

chapter 9|20 pages

Sample Size for Comparing Variabilities

chapter 11|24 pages

Drug Interchangeability

chapter 12|28 pages

Issues on Immunogenicity Studies

chapter 13|18 pages

CMC Requirements for Biological Products

chapter 15|20 pages

Stability Analysis of Biosimilar Products

chapter 16|22 pages

Assessing Biosimilarity Using Biomarker Data

chapter 17|22 pages

Current Issues in Biosimilar Studies