Biosimilars and Interchangeable Biologics : Strategic Elements (Hardcover, 2 ed)

Chapter 1 Introduction to Biosimilar and Interchangeable Products - Evolution, Challenges, and Future Directions Chapter 2 Intellectual Property and Patent Landscape for Biosimilars - Global Perspectives and Strategic Implications Chapter 3 European Regulatory Framework for Biosimilar Medicines - Comprehensive Guide to EMA Requirements and Assessment Paradigms Chapter 4 EMA Approved Biosimilars: Evolution, Innovation, and the Path Forward Chapter 5 FDA Regulatory Framework for Biosimilars: Evolution of the BPCIA and Contemporary Regulatory Landscape Chapter 6 Global Regulatory Landscape for Biosimilars - Contemporary Framework Evolution and Emerging Market Transformation Chapter 7 Global Regulatory Requirements for Biosimilar Approval, Contemporary Framework Evolution and Strategic Assessment Chapter 8 Quality Characterization and Analytical Comparison of Biosimilar Monoclonal Antibodies: A Japanese Perspective Assessment Chapter 9 Quality Characterization and Regulatory Assessment of Biosimilar Monoclonal Antibodies: United States and European Union Perspectives Chapter 10 Quality Characterization and Regulatory Assessment of Non-Antibody Biological Drug Biosimilars - Contemporary Tri-Jurisdictional Analysis and Advanced Methodological Frameworks Chapter 11 Quality and Lifecycle Management for Biosimilar and Biological Products - Contemporary Framework Evolution and Advanced Technological Integration Chapter 12 US Biosimilar Commercialization - Contemporary Market Dynamics and Strategic Evolution in the Post-Patent Cliff Era Chapter 13 Global Biosimilar Commercialization - Contemporary International Market Dynamics and Strategic Excellence in the Era of Regulatory Harmonization