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.

Autorentext

Hiten Gutka PhD., is an Associate Director Formulation Development at Oncobiologics Inc. where he works on biosimilar drug product development. He worked on formulation and stabilization of novel insulin analogues at Thermalin Diabetes LLC. He did a co-op at Medimmune LLC, in the Formulation and Drug Product Development group. Hiten got his PhD in Pharmacognosy (Pharmaceutical Biotechnology track) from University of Illinois at Chicago (UIC), College of Pharmacy. Dr. Gutka worked at Biocon, USV and Reliance Biopharmaceuticals in India, on analytical and pharmaceutical development of biosimilar Insulins and other biosimilars including cytokines and hormones. He got his Bachelors in Pharmaceutical Sciences from University of Mumbai, India and Masters in Pharmaceutical Sciences from University Institute of Chemical Technology, Mumbai, India. Hiten is a member of the American Association of Pharmaceutical Sciences (AAPS). He serves on the editorial board of the journal mAbs.

Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at MedImmune. He has participated in industry initiatives related to Quality by Design, analytical method development and validation, and sterile drug product bioburden testing. He has 23 years of experience in drug discovery, pre-clinical and clinical study design and analysis, translational sciences, biopharmaceutical development, manufacturing, and regulatory submissions. He has authored 5 statistical books and published 14 book chapters and more than 90 papers. He received his Bachelor's and Master's degrees in Applied Mathematics from Peking University, and Ph.D. in Statistics from the University of Pittsburgh. Shefali Kakar PhD., is an Executive Director, Global Head Respiratory, in the Novartis Pharmacokinetic Sciences group. She is responsible for overseeing all aspects of pharmacokinetics sciences (ADME, PK/PD, and clinical pharmacology) for the respiratory portfolio ranging from early discovery to full development. Dr. Kakar has over 15 years of industrial experience and has been involved in discovery and development of over 40 small molecules and protein therapeutics, including biosimilars. Prior to joining Novartis, Dr. Kakar worked at Pfizer and also served as an Adjunct faculty at the Brown University. She received her PhD in Pharmacology from University of Michigan.

Inhalt

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.