Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development (AAPS Advances in the Pharmaceutical Sciences Series, 34)

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe. Front Matter ....Pages i-xxiii Front Matter ....Pages 1-1 Biosimilars 101: An Introduction to Biosimilars (Anna Rose Welch)....Pages 3-21 Innovation, Patents and Biologics: The Road to Biosimilar Competition: Factors Influencing Investment, Business Decisions and Marketing of Biosimilars (Erwin A. Blackstone, Joseph P. Fuhr)....Pages 23-48 The Changing US Reimbursement Landscape and Biosimilars (Molly Burich)....Pages 49-73 Litigation-Related Issues Under the Biologics Price Competition and Innovation Act (Brian D. Coggio, Ron Vogel, Tasha Francis)....Pages 75-104 Front Matter ....Pages 105-105 Design and Implementation of Successful Regulatory Strategies in Biosimilar Development (Kamali Chance)....Pages 107-121 Clinical Information Requirements for Biosimilar Biologic Drug Approvals in Canada (Bradley J. Scott, Jian Wang)....Pages 123-144 EU Perspective on Biosimilars (Pekka Kurki, Niklas Ekman)....Pages 145-169 Front Matter ....Pages 171-171 Biosimilars Drug Substance Development and Manufacturing: Effective CMC Strategy (Adriana E. Manzi, Michiel E. Ultee)....Pages 173-186 QbD in Biopharmaceutical Manufacturing and Biosimilar Development (Christina Vessely, Christopher Bussineau)....Pages 187-219 Drug Product Considerations for Biosimilars (Satish K. Singh, Susanne Jörg, Hanns-Christian Mahler)....Pages 221-258 Front Matter ....Pages 259-259 Principles of Analytical Similarity Assessment (Kristof Vandekerckhove, Russell Reeve)....Pages 261-303 Application of an Adaptive Analytical Characterization Strategy to Support Development and Approval of Biosimilars (John P. Gabrielson, Jared A. Young, Brent S. Kendrick)....Pages 305-320 Higher Order Structure Methods for Similarity Assessment (Jared A. Young, John P. Gabrielson)....Pages 321-337 Protein Conformational Array Technology for Biosimilar Higher Order Structure Analysis (Xing Wang, Wen-Rong Lie, Jehangir Mistry)....Pages 339-362 Protein Particulates and Biosimilar Development: Analytical Tools and Therapeutic Implications (Aaron B. Krueger, Matthew D. Brown)....Pages 363-391 Biological Activity Assays for Antibody Therapeutics (Xu-Rong Jiang, Anthony Mire-Sluis)....Pages 393-430 Statistical Considerations for Demonstration of Analytical Similarity (Harry Yang, Richard K. Burdick, Aili Cheng, Richard O. Montes)....Pages 431-468 Front Matter ....Pages 469-469 Comparative Clinical Studies for Biosimilars as Part of a Stepwise Approach (Thomas E. Gwise)....Pages 471-487 Immunogenicity Assessment of Biosimilars: A Multidisciplinary Perspective (Paul Chamberlain, Pekka Kurki)....Pages 489-542 Interchangeability Study Design and Analysis (Harry Yang, Dongyue Fu, Lorin Roskos)....Pages 543-570 Extrapolation (Peijuan Zhu, Andrej Skerjanec)....Pages 571-599 Totality of Evidence and the Role of Clinical Studies in Establishing Biosimilarity (Hillel P. Cohen, William C. Lamanna, Martin Schiestl)....Pages 601-628 Front Matter ....Pages 629-629 Pharmacovigilance of Biosimilars: Global Experience and Perspective (Thomas Felix, Binakumari Patel, Brian D. Bradbury, Gustavo Grampp)....Pages 631-652 Development and Commercialization of Biosimilars in India: Current Regulatory and Clinical Experience (Anurag S. Rathore, Srishti Joshi, Ankita Bhargava, Neh Nupur)....Pages 653-674 Immunogenicity and Adverse Reactions to Biosimilar Erythropoietin Products in Thailand: The Significance of Science and Quality Driven Process for Approval (Kearkiat Praditpornsilpa, Anunchai Assawamakin, Kriang Tungsanga)....Pages 675-691 Back Matter ....Pages 693-709