Biosimilars and Biobetters: Positioning for a New Market

Published by: Biophoenix Limited

Published: Jul. 1, 2009 - 275 Pages

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

1.2.1.1 Glycosylation

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

1.5.1 EU

1.5.2 US

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2.4.5 Biosimilars approved, rejected and withdrawn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

3.4.5 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

6.5.1 Bioton SA

6.6 Companies headquartered in the Netherlands

6.6.1 DSM NV

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

5.12.1 Bioclones

6.13 Companies headquartered in Iran

6.13.1 CinnGen Inc

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 á

Table 4.11 Interferons â

Table 4.12 Interferons ã

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)

Abstract

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