Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development

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.