Table of Contents
Front Cover
List of Tables
About Biophoenix
About the Authors
Legal Notice
Executive Summary
- Chapter 1 First-generation biologics
- Chapter 2 Biosimilars and follow-on biologics
- Chapter 3 Biobetters
- Chapter 4 Peptide, protein and other biosimilar targets
- Chapter 5 Monoclonal antibody biosimilar targets
- Chapter 6 Company profiles
- Chapter 7 Market analysis
Chapter 1 First-generation biologics
- 1.0 Chapter Summary
- 1.1 Introduction
- 1.2 Background on proteins
- 1.2.1 Post-translational modifications
- 1.3 Production of therapeutic peptides and proteins
- 1.3.1 Chemical synthesis
- 1.3.2 Recombinant technology
- 1.3.2.1 Traditional mammalian cell culture
- 1.3.2.2 Increasing production yields
- 1.4 Characterization and equivalence testing
- 1.4.1 Analytical methods
- 1.4.2 Bioassays
- 1.4.3 Limitations
- 1.4.4 Pharmacokinetics and pharmacodynamics
- 1.4.5 Clinical studies
- 1.4.6 Immunogenicity studies
- 1.5 Regulatory pathways
Chapter 2 Biosimilars and follow-on biologics
- 2.0 Chapter Summary
- 2.1 Introduction
- 2.2 Issues of comparability
- 2.3 The INN nomenclature system
- 2.4 Regulatory pathway: EU
- 2.4.1 General guidelines
- 2.4.2 Guidelines on non-clinical issues
- 2.4.3 Guidelines on clinical issues
- 2.4.4 Guidelines on immunogenicity assessment
- 2.4.5 Biosimilars approved, rejected and withdrawn
- 2.4.6 Outstanding issues
- 2.5 Regulatory developments in the US
- 2.5.1 Biologics regulated under NDAs
- 2.5.2 Proposals for a biosimilars pathway
- 2.5.2.1 H.R. 1427 biosimilars bill
- 1.5.2.2 Pathway for Biosimilars Act
- 2.5.3 FDA' s stance on immunogenicity issues
- 2.6 Initiatives outside the EU/US
- 2.7 Patenting issues
- 2.7.1 Background
- 2.7.2 Patent expirations of biologics
Chapter 3 Biobetters
- 3.0 Chapter Summary
- 3.1 Technologies for improving biologics
- 3.2 Improving parenteral delivery of biologics
- 3.2.1 Introduction
- 3.2.2 Formulations and devices
- 3.2.3 Half-life extension technologies
- 3.2.3.1 PEGylation
- 3.2.3.2 Alternatives to PEGylation
- 3.2.3.3 Glyco-engineering
- 3.2.3.4 Other approaches
- 3.2.4 Depot systems
- 3.3 Advances in nonparenteral delivery
- 3.3.1 Nasal delivery
- 3.3.2 Pulmonary delivery
- 3.3.3 Other approachers
- 3.4 Enhanced production systems
- 3.4.1 Mammalian cells
- 3.4.2 Non-mammalian cells
- 3.4.3 Transgenic animal bioreactors
- 3.5 Chemical protein synthesis
- 3.5.1 Chemoselective ligation
Chapter 4 Peptide, protein and other biosimilar targets
- 4.0 Chapter Summary
- 4.1 Introduction
- 4.2 Peptides
- 4.2.1 Somatostatins and other hGH antagonists
- 4.2.2 Vasopressins
- 4.2.3 Cyclosporins
- 4.2.4 Calcitonins
- 4.2.5 LHRH
- 4.2.6 Hirudins
- 4.2.7 Glucagons and their analogs
- 4.2.8 Glatiramer
- 4.2.9 Selected other peptides
- 4.3 Recombinant unglycosylated proteins
- 4.3.1 Insulins
- 4.3.1.1 Biosimilars rejected (EU)
- 4.3.2 IGF-1
- 4.3.3 Growth hormone
- 4.3.3.1 Biosimilars approved (EU)
- 4.3.3.2 Biosimilar for approval (EU)
- 4.4 Recombinant proteins (mainly unglycosylated)
- 4.4.1 Il-2 and other interleukins
- 4.4.2 Interferons-alpha
- 4.4.2.1 Biosimilars rejected (EU)
- 4.4.3 Interferons-beta
- 4.4.4 Interferons-gamma
- 4.4.5 G-CSF
- 4.4.5.1 Biosimilars approved (EU)
- 4.5 Recombinant glycosylated proteins
- 4.5.1 FSH
- 4.5.2 Lysosomal enzymes
- 4.5.3 GM-CSF
- 4.5.4 Erythropoietins
- 4.5.4.1 First-generation products
- 4.5.4.2 Next-generation products
- 4.5.4.3 Biosimilars approved (EU)
- 4.5.5 Factors VIII
- 4.5.6 Factors IX
- 4.5.7 Factors VIIa
- 4.5.8 Plasminogen activators (thrombolytics)
- 4.5.9 Protein C-based anticoagulants
- 4.5.10 Selected other proteins
- 4.6 Thrombin inhibitors (anticoagulants)
- 4.7 Vaccines
- 4.8 Botulinum toxins
Chapter 5 Monoclonal antibody biosimilar targets
- 5.0 Chapter Summary
- 5.1 Introduction
- 5.1.1 Intact mAbs
- 5.1.2 mAb fragments
- 5.1.3 Fc-based fusion proteins
- 5.1.4 Other mAb formats
- 5.2 Evolution of mAbs
- 5.2.1 Murine mAbs
- 5.2.2 Chimeric mAbs
- 5.2.3 Humanized mAbs
- 5.2.4 Fully human mAbs
- 5.3 Production of therapeutic recombinant mAbs
- 5.3.1 Mammalian cell culture production systems
- 5.3.1.1 Manipulating mAb glycosylation profiles
- 5.3.2 Nonmammalian production systems
- 5.3.3 Enhancing mAb serum half-life
- 5.3.4 Patenting of mAbs
- 5.4 Monoclonals for chronic inflammatory diseases
- 5.4.1 TNF antagonists
- 5.4.1.1 Etanercept
- 5.4.1.2 Infliximab
- 5.4.1.3 Adalimumab
- 5.4.1.4 Cimzia (certolizumab pegol)
- 5.4.2 Other monoclonals
- 5.4.2.1 Natalizumab
- 5.4.2.2 Abatacept and belatacept
- 5.4.2.3 Rituximab
- 5.4.2.4 Tocilizumab
- 5.4.2.5 Omalizumab
- 5.4.2.6 Efalizumab
- 5.4.2.7 Daclizumab
- 5.5 Cancer monoclonals
- 5.5.1 Unconjugated intact mAbs
- 5.5.1.1 Rituximab
- 5.5.1.2 Trastuzumab
- 5.5.1.3 Cetuximab
- 5.5.1.4 Panitumumab
- 5.5.1.5 Bevacizumab
- 5.5.2 Immunoconjugates
- 5.6 Other monoclonals
- 5.6.1 Ranibizumab
- 5.6.2 Palivizumab
- 5.6.3 Abciximab
Chapter 6 Company profiles
- 6.0 Chapter Summary
- 6.1 Companies headquartered in the US
- 6.1.1 Abraxis BioScience Inc
- 6.1.2 Aequus BioPharma Inc
- 6.1.3 Biogen Idec Inc
- 6.1.4 Dynavax Technologies Corp
- 6.1.5 GTC Biotherapeutics Inc
- 6.1.6 Hospira Inc
- 6.1.7 Itero Biopharmaceuticals
- 6.1.8 Merck & Co Inc
- 6.1.9 Momenta Pharmaceuticals Inc
- 6.1.10 Mylan Inc
- 6.1.11 Phage Biotechnology Corp
- 6.1.12 Prolong Pharmaceuticals
- 6.2 Companies headquartered in Canada
- 6.2.1 Apotex Inc
- 6.2.2 Viropro Inc
- 6.3 Companies headquartered in Germany
- 6.3.1 BioGeneriX AG
- 6.3.2 Sandoz
- 6.3.3 Stada Arzneimittel AG
- 6.4 Companies headquartered in France
- 6.4.1 LFB S.A.
- 6.4.2 Merieux Alliance
- 6.5 Companies headquartered in Poland
- 6.6 Companies headquartered in the Netherlands
- 6.7 Companies headquartered in Switzerland
- 6.7.1 Lonza Group Ltd
- 6.7.2 Selexis SA
- 6.8 Companies headquartered in India
- 6.8.1 Avesta Biotherapeutic and Research Pvt Ltd
- 6.8.2 Biocon Ltd
- 6.8.3 Dr Reddy' s Laboratories Ltd
- 6.8.4 Emcure Pharmaceuticals Ltd
- 6.8.5 Intas Biopharmaceuticals Ltd
- 6.8.6 Ranbaxy Laboratories Ltd
- 6.8.7 Reliance Life Sciences Pvt Ltd
- 6.8.8 Wockhardt Ltd
- 6.8.9 Zenotech Technologies Ltd
- 6.9 Companies headquartered in Israel
- 6.9.1 Teva Pharmaceutical Industries Ltd
- 6.10 Companies headquartered in South Korea
- 6.10.1 Green Cross
- 6.10.2 LG Life Sciences Ltd
- 6.11 Companies headquartered in China
- 6.11.1 3SBio Inc
- 6.11.2 GeneScience Pharmaceuticals Co Ltd
- 6.11.3 Shenzhen Kexing Biotech Co Ltd
- 6.12 Companies headquartered in South Africa
- 6.13 Companies headquartered in Iran
Chapter 7 Market analysis
- 7.0 Chapter Summary
- 7.1 Introduction
- 7.2 Sales of Innovator and Related Products
- 7.2.1 Anti-TNF antibodies
- 7.2.2 Cancer antibodies
- 7.2.3 Vaccines
- 7.2.4 Peptides and Glycans
- 7.2.5 Erythropoiesis stimulating agents
- 7.2.6 Insulins and IGF-1
- 7.2.7 Interferon-beta
- 7.2.8 Granulocyte Colony Stimulating factor
- 7.2.9 Other antibodies
- 7.2.10 Coagulation Factors
- 7.2.11 Miscellaneous proteins
- 7.2.12 Lysosomal enzymes
- 7.2.13 Human Growth Hormone
- 7.2.14 Interferon-alpha
- 7.2.15 Follicle Stimulating Hormone
- 7.3 Product Analysis and Forecasts to 2013
- 7.4 Geographic Analysis and Forecasts to 2013
- 7.4.1 Effect of uncertain economic conditions
- 7.4.2 European Biosimilars Market
- 7.4.3 US Biosimilars Market
- 7.4.4 Emerging markets
- 7.4.5 Japan
- 7.4.6 Forecasts
- 7.5 Biosimilar challenges and market drivers
Appendix 1 Abbreviations and Acronyms
Appendix 2 Research Methodology
Appendix 3 List of Tables
List of Tables
- Table 1.1 Analytical Procedures Useful for Assessing the Equivalence of
Biotechnological Products
- Table 2.1 Biosimilars in the EU; Outcome of Marketing Authorisation
Applications
- Table 2.2 First US patent expiries of the 25 top-selling biologics (in
2008)
- Table 3.1 Half-life extension technologies for injectable protein delivery
- Table 3.2 Depot technologies for injectable protein delivery
- Table 4.1 Somatostatins and other hGH antagonists
- Table 4.2 Vasopressins
- Table 4.3 Cyclosporins
- Table 4.4 Calcitonins
- Table 4.5 LHRH (luteinizing hormone-releasing hormone) analogs
- Table 4.6 Glucagons and their analogues
- Table 4.7 Insulins and IGF1
- Table 4.8 Human growth hormone (hGH)
- Table 4.9 Interleukin 2 Agents
- Table 4.10 Interferons α
- Table 4.11 Interferons β
- Table 4.12 Interferons γ
- Table 4.13 Granulocyte-colony stimulating factors (G-CSFs)
- Table 4.14 Follicle-stimulating hormone (FSH) agonists
- Table 4.15 Lysosomal Enzymes
- Table 4.16 Granulocyte monocyte colony stimulating factor (GM-CSFs)
- Table 4.17 Erythropoietins (EPOs)
- Table 4.18 Factors VIII
- Table 4.19 Factors IX
- Table 4.20 Factors VIIa
- Table 4.21 Plasminogen Activators
- Table 4.22 Protein C-based Anticoagulants
- Table 4.23 Thrombin Inhibitors
- Table 4.24 Vaccines
- Table 4.25 Miscellaneous Agents
- Table 5.1 TNF Antagonists
- Table 5.2 Monoclonals for cancer and other indications
- Table 5.3 Immunoconjugates for cancer and other indications
- Table 6.1 Characteristics of North American companies developing
biosimilars
- Table 6.2 Characteristics of European companies developing biosimilars
- Table 6.3 Characteristics of Rest-of-World companies developing biosimilars
- Table 7.1 Top Biologics Categories in 2008, with Forecasts to 2013
- Table 7.2 Prominent Biologics by Product Category and Sales in 2008, with
Forecasts to 2013
- Table 7.3 Top 25 Biologics Sales in 2008, with Forecasts to 2013
- Table 7.4 Biosimilars Analysis in 2008 and Forecasts to 2013 ($USM)
- Table 7.5 World Pharma Market by Country, 2008-2013 ($USM)
- Table 7.6 World Biologic Market by Country, 2008-2013 ($USM)
- Table 7.7 World Biosimilar-Susceptible Market by Country, 2008-2013 ($USM)
- Table 7.8 World Biosimilar Market by Country, 2008-2013 ($USM)
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