Full Description
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.
Contents
Section I: Biosimilars, Regulatory landscape, health economics and Intellectual Property landscape.- Biosimilars 101 - An Introduction to Biosimilars.- Innovation, Patents and Biologics: The Road to Biosimilar Competition.- Factors influencing investment, business decisions and marketing of biosimilars.- The Changing US Reimbursement Landscape and Biosimilars.- Litigation-Related Issues Under The Biologics Price Competition and Innovation Act.- Section II: Target Product Profile, QbD, CMC, Biosimilar manufacture platform technologies.- Design and implementation of successful regulatory strategies in biosimilar development.- Health Canada's perspective on the clinical development of biosimilars and related scientific and regulatory challenges.- EU Perspective on Biosimilars.- Section III: Pharmaceutical development of Biosimilars; analytical comparability; higher order structure.- QbD in biopharmaceutical manufacturing and biosimilar development.- Drug Product Development and Manufacturing considerations for biosimilars.- Section IV: Biosimilars- clinical and non-clinical development; immunogenicity; Extrapolation and Interchangeability.- Principles of Analytical Biosimilarity Assessment .- Application of an Adaptive Analytical Characterization Strategy to Support Development and Approval of Biosimilars.- Higher Order Structure methods for similarity assessment.- Protein Conformational Array for Biologics Higher Order Structure Similarity Analysis.- Protein particulates and biosimilar development: analytical tools and therapeutic implications.- Biological activity assays for antibody therapeutics.- Statistical Considerations for Demonstration of Analytical Similarity.- Section V: Biosimilars- Global development and clinical experience.- Comparative clinical studies for biosimilar development.- Immunogenicity assessment of biosimilars: A multidisciplinary perspective.- Interchangeability of biosimilar therapeutics.- Extrapolation of Biosimilars.- Totality of evidence and the role of clinical studies in establishing biosimilarity.- Section VI: Biosimilars- Global Development and Clinical Experience.- Pharmacovigilance of Biosimilars - Global experience and perspective.- Development and Commercialization of Biosimilars in India - Current Regulatory and Clinical Experience.-Immunogenicty and adverse reactions to biocopy erythropoietins: The quality issues.
