دانلود کتاب توسعه بیوژنریک محصولات دارویی
Biosimilar Drug Product Development, 1ed

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

This book is devoted entirely to the development of biosimilar drug products. It covers the scientic factors and/or practical issues that are commonly encountered 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 evaluation and approval of the development of biosimilar products. The stepwise approach starts with analytical similarity assessment for functional and structural characterization 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 efcacy conrmation. 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 indications 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. They at times contain repetition of material, which may shed light on some topics from different directions.

Contents

Chapter 1 Introduction: Scientific Factors in Biosimilar Product Development
Chapter 2 Analytical Characterization: Structural Assessment of Biosimilarity
Chapter 3 Analytical Similarity Assessment
Chapter 4 Characterization of Biosimilar Biologies: The Link between Structure and Functions
Chapter 5 Manufacturing and Process Control Issues: Quality Development of Biosimilar Medicinal Products
Chapter 6 Nonclinical Studies for Biosimilars
Chapter 7 The Clinical Development of Biosimilar Drugs
Chapter 8 Statistical Methods for Assessing Biosimilarity
Chapter 9 Extrapolation of Indications for Biosimilars: Opportunity for Developers and Challenges for Regulators
Chapter 10 Interchangeability, Switchability, and Substitution of Biosimilar Products
Chapter 11 Design and Analysis of Studies for Assessing Interchangeability
Chapter 12 The Role of the Immunogenicity Evaluation for Biosimilars
Chapter 13 Phamnacovigilance of Biosimilars
Chapter 14 Patent Exclusivities Affecting Biosimilars in the United States, Canada, and Europe
Chapter 15 Biosimilars in the EU: Regulatory Guidelines
Chapter 16 Biosimilars and Biologies: The Prospects for Competition
Chapter 17 Plant-Based Production of Biosimilar Drug Products