Biosimilar Drug Product Development

More and more innovative biological products will lose their patents in the com- ing decade. Therefore, in order to reduce costs, attempts will continue to be made to establish an abbreviated regulatory pathway for the approval of biosimilar drug products of the innovator’s biological products. However, owing to the complexity of the structures of biosimilar products and the nature of the manufacturing process, biological products differ from the traditional small-molecule (chemical) drug prod- ucts. Many scientific challenges remain for establishing an abbreviated regulatory pathway for the approval of biosimilar products due to their unique characteristics. This book is devoted entirely to the development of biosimilar drug products. It covers the scientific factors and/or practical issues that are commonly encoun- tered at various stages of research and development of biosimilar products. It is our goal to provide a useful desk reference to scientists and researchers engaged in pharmaceutical/clinical research and the development of biosimilar drug products, those in the regulatory agencies who have to make decisions in the review and approval process of biological regulatory submissions. We hope that this book can serve as a bridge among the pharmaceutical/biotechnology industry, government regulatory agencies, and academia. This book follows the FDA’s and EMA’s proposed stepwise approach for evalua- tion and approval of the development of biosimilar products. The stepwise approach starts with analytical similarity assessment for functional and structural character- ization of critical quality attributes that are relevant to clinical outcomes at various stages of the manufacturing process, in vitro studies for pharmacological activities, additional nonclinical studies if needed, and clinical studies for pharmacokinetic and immunogenicity assessment and efficacy confirmation. Thus, this book consists of 17 chapters. These chapters cover analytical similarity assessment (Chapters 2 through 4), manufacturing process control (Chapter 5), nonclinical studies (Chapter 6), design and analysis for assessing biosimilarity and drug interchangeability (Chapters 8, 10, and 11), pharmacovigilance (Chapter 13) and immunogenicity (Chapter 12), clinical development (Chapter 7), patent exclusivities (Chapter 14), extrapolation of indica- tions for biosimilars (Chapter 9), and other issues (Chapters 15 through 17). The chapters intend to illuminate the many current issues and future directions of the development of biosimilars.

Publication year:2017