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Biologics, Biosimilars, and Biobetters
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Страница 1
Table of Contents
List of Tables
List of Illustrations
Guide
Pages
Biologics, Biosimilars, and Biobetters An Introduction for Pharmacists, Physicians, and Other Health Practitioners
Страница 8
List of Contributors
Foreword
Preface
1 Innovator Biologics, Biosimilars, and Biobetters: Terminology, Nomenclature, and Definitions
KEY POINTS
Abbreviations
1.1 Place of Biologics in Modern Therapeutics
1.2 Background to Terminology, Nomenclature, and Definitions
1.3 Innovator Biologics, Biosimilars, and Biobetters 1.3.1 What Is a Biologic Medicine?
1.3.2 What Is a Biosimilar?
1.3.3 What Is a Biobetter?
1.4 Differences Between Biosimilars and Generic Medicines
1.5 Interchangeability, Switchability, and Substitution 1.5.1 Interchangeability
1.5.2 Switchability
1.5.3 Substitution
1.6 Other Clinical Considerations with Biosimilars 1.6.1 Indication Extrapolation
1.6.2 Nocebo Effect
1.6.3 Immunogenicity Reactions
1.6.4 Definition of Frequency of Adverse Effects
1.6.5 Pharmacovigilance of Biologics
1.7 Manufacture, Delivery, and Naming Considerations 1.7.1 Post‐Translational Modifications (PTMs)
1.7.2 Quality by Design Paradigm
1.7.3 Delivery Devices for Biologics
1.7.4 Naming and Labeling of Biosimilars
1.8 Listing of Approved Biologics 1.8.1 Purple Book in the United States
1.8.2 European Generic Medicines Association (EGA) Biosimilars Handbook
1.9 Biosimilar Initiatives and Organizations
1.9.1 Generics and Biosimilars Initiative (GaBi/GaBI)
1.9.2 Biologics Price Competition and Innovation Act in the United States
1.9.3 Biosimilars Action Plan (USFDA)
1.9.4 NHS England Commissioning Framework for Biological Medicines
1.9.5 PrescQIPP
1.9.6 The Association of the British Pharmaceutical Industry
1.9.7 NHS Scotland
1.9.8 National Institute for Health and Care Excellence
1.9.9 Australian Biosimilar Awareness Initiative
1.9.10 NPS MedicineWise (Australia)
1.10 Common Terms Used in the Biologics Literature
1.10.1 Real‐World Evidence
1.10.2 Patent Dance
1.10.3 Evergreening
1.10.4 Limited Distribution Network
1.10.5 Drug Tendering
1.10.6 Pharmacy and Therapeutics Committees
1.10.7 Quality Use of Medicine
1.10.8 European Public Assessment Report
1.11 Abbreviations Associated with Biologic Medicines
1.12 Concluding Remarks
Acknowledgement
References
2 Approved Biologic Medicines and Biosimilars in Major Regulatory Jurisdictions
KEY POINTS
Abbreviations
2.1 Regulatory Frameworks
2.2 Major Regulatory Jurisdictions 2.2.1 Food and Drug Administration
2.2.2 European Medicines Agency
2.2.3 Pharmaceuticals and Medical Devices Agency (Japan)
2.2.4 Therapeutic Goods Administration (Australia)
2.2.5 Centre of Drug Evaluation, CDE (China)
2.3 Maturation of the Biologic Market
2.4 Player Archetypes in a Maturing Market
2.4.1 Established Biologic Players
2.4.2 Niche Biologic Innovators
2.4.3 Players Looking to Enter the Biologic Space
2.4.4 Biosimilar Players
2.5 Outlook: Landscape of the Biologic Market
2.5.1 Biologics in Nontraditional Biologic Disease Areas
2.6 Technology and Science Innovation in the Long Term? 2.6.1 The Potential of Innovative Technologies
2.6.2 Drug Delivery: Calls for Change
2.6.3 Biologic Asset Deal Frenzy
2.7 The Arrival of Major Biosimilars 2.7.1 Biosimilar Immediacy
2.7.2 Regulatory Hurdles for Biosimilar Launch
2.7.3 Interchangeability and Substitution
2.8 Biosimilars in Emerging Markets
2.9 Top 10 Biologic Drugs in the United States
2.9.1 Humira
®
2.9.2 Rituxan
®
2.9.3 Enbrel
®
2.9.4 Herceptin
®
2.9.5 Avastin
®
2.9.6 Remicade
®
2.9.7 Lantus
®
2.9.8 Neulasta
®
2.9.9 Avonex
®
2.9.10 Lucentis
®
2.10 Top 10 Biologic Drugs in the EU
2.11 Conclusions
References
3 Status of Biologic Drugs in Modern Therapeutics‐Targeted Therapies vs. Small Molecule Drugs
KEY POINTS
Abbreviations
3.1 Biologics in Contemporary Medicine 3.1.1 A History of Drug Development and Commercialization
3.1.2 The Business Model for Chronic Disease
3.1.3 Complexity of Biologics
3.2 Clinical Characteristics of Biologic Drugs 3.2.1 Biologics vs. Small Molecule Drugs
3.2.2 Vaccines
3.2.3 Antibodies
3.2.4 Enzymes
3.2.5 Cytokines
3.2.6 Cytokine‐Interferons
3.2.7 Cytokine‐Interleukins
3.2.8 Tumor Necrosis Factor
3.2.9 Hormones
3.2.10 Blood Factor Products
3.3 rDNA and Biologic Drug Manufacturing
3.4 What Does the Future Hold? 3.4.1 Gene Therapy
3.4.2 Personalized Medicine
3.5 Global Biologics Market
3.6 Summary
References
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