This updated edition explores biosimilar drugs' strategic planning, focusing on legal matters, patents, regulatory pathways, and global affordability. It examines the science, technology, finance, ethics, and politics of biosimilars while presenting strategies for development and lifecycle management.
This updated edition explores biosimilar drugs' strategic planning, focusing on legal matters, patents, regulatory pathways, and global affordability. It examines the science, technology, finance, ethics, and politics of biosimilars while presenting strategies for development and lifecycle management.
Sarfaraz K. Niazi, Ph.D., is an Adjunct Professor at the University of Illinois and University of Houston; he has authored 60+ major books, 200+ research papers, and 200+ patents, mainly in the field of bioprocessing, drug discovery, mRNA vaccines, drug formulations, thermodynamic systems, alcohol aging, nutraceuticals, and treatment of autoimmune diseases. He has established multiple biotechnology projects, from concept to market. He also serves as an advisor to major pharmaceutical and biopharmaceutical companies, regulatory agencies, the FDA, the US Congress, and several heads of state. He is also a patent law practitioner.
Inhaltsangabe
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
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
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