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This new edition explores the strategic planning side of biosimilar drugs and targets the issues surrounding biosimilars that are linked to legal matters. This includes an examination of new regulatory requirements in terms of principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale.
Biosimilars and Interchangeable Biologics: Strategic Elements,
Second edition, examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. The book presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle. Updated throughout, the book covers strategic planning elements that include an overall understanding of the history and the current status of the science and art of biosimilars. As the perception of biosimilars has changed over the last several years, the author provides detailed descriptions of the new legal, regulatory, and commercial characteristics that must be considered. He also addresses the utilization of biosimilars and related biological drugs in expanding world markets, and reviews new strategies and tactics to enable users to create a universal dossier. Finally, there is also an examination of newer technologies that will help reduce the capital costs of manufacturing and bringing biosimilars to market.
The book is intended for pharmaceutical scientists, engineers in biotechnology, regulatory specialists, analytical chemists, and quality assurance specialists in biopharmaceuticals.
List of contents
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
About the author
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.
