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Biotechnology

A Guide to Biosimilars, Biogenerics and Follow-on Biologics

 

Publication Date January 2007
Publisher Scrip Reports
Product Type Report
Pages not applicable
ISBN Number not applicable
Product Code SCR00012

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Summary

Clinical trials of medical devices are costly, time-consuming and can make or break the fortunes of a company. In addition, European laws create a labyrinth of regulations for clinical trials that needs to be navigated with skill, dexterity and knowledge. Therefore this report will furnish the reader with information on why, when and how to conduct a clinical trial, and guide you through all stages of the trial: from its preparation to capitalising on the results, highlighting the potential pitfalls along the way.

The strategies discussed in this report can be applied successfully to any market in the world.

However, the legislation that governs the conduct of clinical trials varies globally and, therefore, this report cover those countries which are governed by the European Commission Directives.

Although this report traces the development of a device from its design to final marketing, it will only discuss these events in terms of how they affect and can be affected by clinical trials, and the focus of the report will be on constructing efficient and effective clinical trials for medical devices in general, with some specific examples.

The report covers clinical evaluation, which can take two forms: a collation of scientific literature or the results of clinical trials. A clinical trial, more properly termed a clinical investigation when referring to a medical device, can be described as: A systematic study of human subjects to verify the safety and performance of a specific medical device under normal conditions of use.

Clinical trials (investigations) therefore act as a method of predicting the future and long-term behaviour, efficiency and safety of a device in situations where there are historical data on the device that can act as a valid predictor of its performance. This is a legal requirement to gain marketing approval for a medical device in the countries covered in this course and can also act as a marketing tool for a company to show objective evidence of the advantage of its product over a competitive technology and lever purchasing decisions.

Contents

  • Chapter 1 Introduction
    • 1.1 The Advent of Biosimilars
    • 1.2 The Role of Patents in The Drug Industry
    • 1.3 Protein-Based Biopharmaceuticals
    • 1.3.1 Background
    • 1.3.2 Manufacturing Processes
    • 1.3.3 Protein Characterisation
    • 1.3.4 The Global Market
    • 1.4 Biosimilars
    • 1.4.1 Market Drivers and Inhibitors
    • 1.4.2 The Inn Nomenclature System
    • 1.5 Biosimilars Regulation
    • 1.5.1 The Eu Position
    • 1.5.2 US Pathways
    • 1.5.2.1 Government Initiatives
  • Chapter 2 Product Overview
    • 2.1 Introduction
    • 2.1.1 Approved Follow-on Proteins/Biosimilars
    • 2.2 Characteristics of High-Selling Peptides and Proteins
    • 2.2.1 Products with Expired Patents
    • 2.2.2 Challenging Originator's Patents
    • 2.3 Target Products for Fob/Biosimilar Development
    • 2.4 Peptides (Nda Pathway)
    • 2.4.1 Octreotide
    • 2.4.2 Desmopressin
    • 2.4.3 Cyclosporine
    • 2.4.4 Calcitonin
    • 2.4.5 Eptifibatide
    • 2.4.6 Lhrh
    • 2.4.7 Bivalirudin
    • 2.4.8 Enfuvirtide
    • 2.4.9 Glucagon
    • 2.4.10 Nesiritide
    • 2.4.11 Teriparatide
    • 2.5 Recombinant Non-Glycosylated Proteins (Nda Pathway)
    • 2.5.1 Insulin
    • 2.5.2 Somatropin
    • 2.5.3 Lepirudin
    • 2.6 Recombinant Non-Glycosylated Proteins (Bla Pathway)
    • 2.6.1 Interleukin-2
    • 2.6.2 Interferons
    • 2.6.2.1 Interferon-Alfa
    • 2.6.2.2 Interferon-Beta
    • 2.6.2.3 Interferon-Gamma
    • 2.6.3 Granulocyte-Csf
    • 2.6.4 Interleukin-11
    • 2.6.5 Anakinra
    • 2.6.6 Other Proteins
    • 2.7 Recombinant Glycosylated Proteins (Nda Pathway)
    • 2.7.1 Follitropin
    • 2.7.2 Thyrotropin
    • 2.7.3 Urokinase
    • 2.7.4 Glucocerebrosidase
    • 2.7.5 Other Products
    • 2.8 Recombinant Glycosylated Proteins (Bla Pathway)
    • 2.8.1 Becaplermin
    • 2.8.2 Granulocyte-Macrophage-Csf
    • 2.8.3 Erythropoietin
    • 2.8.4 Dnase
    • 2.8.5 Factor Viia
    • 2.8.6 Factor Ix
    • 2.8.7 Factor Viii
    • 2.8.8 Activated Protein C
    • 2.8.9 Tissue Plasminogen Activator
    • 2.8.10 Monoclonal Antibodies
    • 2.8.10.1 Chimaeric Mabs
    • 2.8.10.2 Humanised Mabs
    • 2.8.10.3 Human Mabs and Fusion Proteins
    • 2.8.11 Other Proteins
    • 2.9 Strategies of Originator Companies
    • 2.9.1 Increasing Product Patent Protection
    • 2.9.2 next-Generation Branded Products
    • 2.9.3 Development of Authorised Generics
    • 2.9.4 Price Reduction of The Branded Product
  • Chapter 3 Approaches to The Characterisation of Biosimilars
    • 3.1 Introduction
    • 3.2 Problems in Characterising Biologics
    • 3.2.1 Definitions
    • 3.2.2 Types of Biologic
    • 3.2.2.1 Peptides
    • 3.2.2.2 Non-Glycosylated Proteins
    • 3.2.2.3 Glycosylated Proteins
    • 3.2.2.4 Monoclonal Antibodies
    • 3.2.3 Equivalence Issues
    • 3.2.4 Post-Translational Modifications
    • 3.2.5 Effect of Microheterogeneity
    • 3.2.6 Pharmacokinetics
    • 3.2.7 Pharmacodynamics
    • 3.2.8 Clinical Efficacy
    • 3.2.9 Immunogenicity
    • 3.3 Analytical Methods
    • 3.3.1 Introduction
    • 3.3.2 Chromatography
    • 3.3.3 Protein Sequencing
    • 3.3.4 Mass Spectrometry
    • 3.3.5 Nuclear Magnetic Resonance
    • 3.3.6 Electrophoresis
    • 3.3.7 Western Blotting
    • 3.3.8 Bioassays
    • 3.3.9 Other Procedures
    • 3.4 Case Studies
    • 3.4.1 Introduction
    • 3.4.2 Erythropoietin
    • 3.4.2.1 European Position
    • 3.4.2.2 US Position
    • 3.4.2.3 Immunogenicity: Pure Red Cell Aplasia
    • 3.4.2.4 Immunogenicity: Product Consistency Issues
    • 3.4.3 Somatotropin
    • 3.4.3.1 European Position
    • 3.4.3.2 US Position
    • 3.4.3.3 Immunogenicity Issues
    • 3.4.4 Alpha Interferon
    • 3.4.4.1 European Position
    • 3.4.4.2 US Position
  • Chapter 4 Key Biosimilars Players
    • 4.1 Preface
    • 4.2 India-Based Companies
    • 4.2.1 Biocon
    • 4.2.1.1 Company Overview
    • 4.2.1.2 Biosimilar Strategy
    • 4.2.1.3 Biosimilar Pipeline
    • 4.2.1.4 Biosimilar Collaborations
    • 4.2.2 Dr Reddy's
    • 4.2.2.1 Company Overview
    • 4.2.2.2 Biosimilar Strategy
    • 4.2.2.3 Biosimilar Pipeline
    • 4.2.3 Reliance Life Sciences/Genemedix
    • 4.2.3.1 Company Overview
    • 4.2.3.2 Biosimilar Strategy
    • 4.2.3.3 Biosimilar Pipeline
    • 4.2.3.4 Biosimilar Collaborations
    • 4.2.4 Ranbaxy Laboratories
    • 4.2.4.1 Company Overview
    • 4.2.4.2 Biosimilar Strategy
    • 4.2.4.3 Biosimilar Pipeline
    • 4.2.4.4 Biosimilar Collaborations
    • 4.3 Germany-Based Companies
    • 4.3.1 Ratiopharm/Biogenerix
    • 4.3.1.1 Overview
    • 4.3.1.2 Biosimilar Strategy
    • 4.3.1.3 Biosimilar Pipeline
    • 4.3.1.4 Biosimilar Collaborations
    • 4.3.2 Sandoz International (Novartis)
    • 4.3.2.1 Company Overview
    • 4.3.2.2 Biosimilar Strategy
    • 4.3.2.3 Biosimilar Pipeline
    • 4.3.2.4 Biosimilar Collaborations
    • 4.3.3 Stada Arzneimittel/Bioceuticals Arzneimittel
    • 4.3.3.1 Company Overview
    • 4.3.3.2 Biosimilar Strategy
    • 4.3.3.3 Biosimilar Pipeline
    • 4.3.3.4 Biosimilar Collaborations
    • 4.4 Other Eu-Based Companies
    • 4.4.1 Bioton/Biopartners
    • 4.4.1.1 Company Overview
    • 4.4.1.2 Biosimilar Strategy
    • 4.4.1.3 Biosimilar Pipeline
    • 4.4.1.4 Biosimilar Collaborations
    • 4.4.2 Dsm (Dsm Biologicals)
    • 4.4.2.1 Company Overview
    • 4.4.2.2 Biosimilar Strategy
    • 4.4.2.3 Biosimilar Pipeline
    • 4.4.2.4 Biosimilar Collaborations
    • 4.5 US-Based Companies
    • 4.5.1 Barr Pharmaceuticals/Pliva
    • 4.5.1.1 Company Overview
    • 4.5.1.2 Biosimilar Strategy
    • 4.5.1.3 Biosimilar Pipeline
    • 4.5.1.4 Biosimilar Collaborations
    • 4.5.2 Hospira/Mayne Pharma
    • 4.5.2.1 Company Overview
    • 4.5.2.2 Biosimilar Strategy
    • 4.5.2.3 Biosimilar Pipeline
    • 4.5.2.4 Biosimilar Collaborations
    • 4.5.3 Dynavax Technologies/Rhein Biotech
    • 4.5.3.1 Company Overview
    • 4.5.3.2 Biosimilar Strategy
    • 4.5.3.3 Biosimilar Pipeline
    • 4.5.3.4 Biosimilar Collaborations
    • 4.6 Canada-Based Companies
    • 4.6.1 Cangene
    • 4.6.1.1 Company Overview
    • 4.6.1.2 Biosimilar Strategy
    • 4.6.1.3 Biosimilar Pipeline
    • 4.6.2 Microbix
    • 4.6.2.1 Company Overview
    • 4.6.2.2 Biosimilar Strategy
    • 4.6.2.3 Biosimilar Pipeline
    • 4.6.2.4 Biosimilar Collaborations
    • 4.7 Other Companies
    • 4.7.1 Teva Pharmaceutical Industries/Sicor
    • 4.7.1.1 Company Overview
    • 4.7.1.2 Biosimilar Strategy
    • 4.7.1.3 Biosimilar Pipeline
    • 4.7.1.4 Biosimilar Collaborations
  • Chapter 5 Markets for Biosimilars
    • 5.1 Introduction
    • 5.2 Leading Drug Classes
    • 5.3 Major Players
    • 5.4 Market Outlook
    • 5.5 Pricing of Biosimilars
    • 5.6 Profitability of Biosimilars
    • 5.7 Substitutability and Interchangeability
    • 5.8 World Pharmaceutical Market Overview
    • 5.9 World Market for Protein Biopharmaceuticals
    • 5.10 Approved Biosimilar Products
    • 5.10.1 US
    • 5.10.2 Europe
    • 5.11 Forecasts by Product
    • 5.11.1 Erythropoietin
    • 5.11.2 Insulin
    • 5.11.3 Interferons
    • 5.11.4 Granulocyte Colony Stimulating Factor
    • 5.11.5 Somatotropins
    • 5.11.6 Other Proteins and Peptides
    • 5.12 Forecasts by Region
  • Chapter 6 Trends and Opportunities
    • 6.1 Biosimilars Market Gaining Momentum
    • 6.2 Competing through Superior Delivery
    • 6.3 Diversifying Biosimilar Pipelines
    • 6.4 Tackling Immunogenicity
    • 6.5 Expanding The Range of Cell Production Systems
    • 6.6 Exploring Transgenic Production Systems
    • 6.7 Developing Cell-Free Protein Synthesis
  • List of tables
    • Table 1.1 Leading Protein Products in 200621
    • Table 1.2 Leading Monoclonal Antibody Products in 2006
    • Table 2.1 Peptides (Nda Pathway)
    • Table 2.2 Recombinant Non-Glycosylated Proteins (Nda Pathway)51
    • Table 2.3 Recombinant Non-Glycosylated Proteins (Bla Pathway)
    • Table 2.4 Recombinant Glycosylated Proteins (Nda Pathway)
    • Table 2.5 Recombinant Glycosylated Proteins (Bla Pathway)
    • Table 2.6 Patents - Peptides (Nda Pathway)
    • Table 2.7 Patents - Recombinant Non-Glycosylated Proteins (Nda Pathway)68
    • Table 2.8 Patents - Recombinant Non-Glycosylated Proteins (Bla Pathway)
    • Table 2.9 Patents - Recombinant Glycosylated Proteins (Nda Pathway)
    • Table 2.10 Patents - Recombinant Glycosylated Proteins (Bla Pathway)
    • Table 2.11 Commercialisation of Candidate Biosimilars
    • Table 2.12 Candidate Biosimilars by Gene Target
    • Table 2.13 Launched Peptides and Proteins by Primary Pharmacology Description
    • Table 2.14 Candidate Biosimilars (Interferon Alpha)
    • Table 2.15 Candidate Biosimilars (Insulin)
    • Table 2.16 Candidate Biosimilars (Erythropoietin)
    • Table 2.17 Candidate Biosimilars (Factor Viii)
    • Table 2.18 Candidate Biosimilars (Cyclosporin)
    • Table 2.19 Candidate Biosimilars (Granulocyte Stimulating Factor)
    • Table 2.20 Candidate Biosimilars (Interferon Beta)
    • Table 2.21 Candidate Biosimilars (Calcitonin)116
    • Table 2.22 Candidate Biosimilars (Lhrh)
    • Table 2.23 Candidate Biosimilars (Interleukin 2)121
    • Table 2.24 Candidate Biosimilars (Factor Ix)
    • Table 2.25 Candidate Biosimilars (Tissue Plasminogen Activator)
    • Table 2.26 Candidate Biosimilars (Urokinase Plasminogen Activator)
    • Table 2.27 Candidate Biosimilars (Follitropin)
    • Table 2.28 Candidate Biosimilars (Somatotropin)
    • Table 2.29 Candidate Biosimilars (Granulocyte Macrophage Colony Stimulating Factor)
    • Table 2.30 Candidate Biosimilars (Interferon Gamma)142
    • Table 2.31 Candidate Biosimilars (Octreotide)
    • Table 2.32 Candidate Biosimilars (Desmopressin)145
    • Table 2.33 Candidate Biosimilars (Factor Viia)
    • Table 2.34 Candidate Biosimilars (Protein C)
    • Table 2.35 Candidate Biosimilars (Teriparatide)
    • Table 2.36 Candidate Biosimilars (Glucocerebrosidase)
    • Table 2.37 Candidate Biosimilars (Hirudin)
    • Table 2.38 Candidate Biosimilars (Bevacizumab)
    • Table 2.39 Candidate Biosimilars (Enfuvirtide)
    • Table 2.40 Candidate Biosimilars (Glucagon)
    • Table 2.41 Candidate Biosimilars (Interleukin 11)152
    • Table 2.42 Candidate Biosimilars (Thyrotropin)
    • Table 2.43 Candidate Biosimilars (Abciximab)
    • Table 2.44 Candidate Biosimilars (Adalimumab)153
    • Table 2.45 Candidate Biosimilars (Alemtuzumab)
    • Table 2.46 Candidate Biosimilars (Anakinra)
    • Table 2.47 Candidate Biosimilars (Aprotinin)
    • Table 2.48 Candidate Biosimilars (Becaplermin)
    • Table 2.49 Candidate Biosimilars (Cetuximab)
    • Table 2.50 Candidate Biosimilars (Dnase)
    • Table 2.51 Candidate Biosimilars (Efalizumab)156 Table 2.52 Candidate Biosimilars (Eptifibatide)
    • Table 2.53 Candidate Biosimilars (Etanercept)
    • Table 2.54 Candidate Biosimilars (Gemtuzumab)
    • Table 2.55 Candidate Biosimilars (Infliximab)158
    • Table 2.56 Candidate Biosimilars (Natalizumab)
    • Table 2.57 Candidate Biosimilars (Nesiritide)
    • Table 2.58 Candidate Biosimilars (Omalizumab)
    • Table 2.59 Candidate Biosimilars (Palivizumab)
    • Table 2.60 Candidate Biosimilars (Rituximab)
    • Table 2.61 Candidate Biosimilars (Trastuzumab)
    • Table 3.1 Examples of Post-Translational Modifications
    • Table 3.2 Analytical Procedures Useful for Assessing The Equivalence of Biotechnological Products
    • Table 5.1 Leading Protein Drug Classes in 2006
    • Table 5.2 World Pharma Market by Therapeutic Category, 2006-2011
    • Table 5.3 World Pharma Market by Region, 2006-2011208
    • Table 5.4 Biopharmaceuticals Market by Application in 2006 and 2011
    • Table 5.5 Biopharmaceuticals Market by Company in 2006 and 2011210
    • Table 5.6 Biopharmaceuticals Market by Protein in 2006 and 2011
    • Table 5.7 Biosimilars Market by Protein in 2006 and 2011
    • Table 5.8 Biopharmaceuticals Market by Region in 2006 and 2011221
    • Table 5.9 Biosimilars Market by Region in 2006 and 2011
    • Table 6.1 Recently Published Cell-Free Protein Synthesis Patents and Applications
    • Table 2.22 Candidate Biosimilars (Lhrh)
    • Table 2.23 Candidate Biosimilars (Interleukin 2)121
    • Table 2.24 Candidate Biosimilars (Factor Ix)
    • Table 2.25 Candidate Biosimilars (Tissue Plasminogen Activator)
    • Table 2.26 Candidate Biosimilars (Urokinase Plasminogen Activator)
    • Table 2.27 Candidate Biosimilars (Follitropin)
    • Table 2.28 Candidate Biosimilars (Somatotropin)
    • Table 2.29 Candidate Biosimilars (Granulocyte Macrophage Colony Stimulating Factor)
    • Table 2.30 Candidate Biosimilars (Interferon Gamma)142
    • Table 2.31 Candidate Biosimilars (Octreotide)
    • Table 2.32 Candidate Biosimilars (Desmopressin)145
    • Table 2.33 Candidate Biosimilars (Factor Viia)
    • Table 2.34 Candidate Biosimilars (Protein C)
    • Table 2.35 Candidate Biosimilars (Teriparatide)
    • Table 2.36 Candidate Biosimilars (Glucocerebrosidase)
    • Table 2.37 Candidate Biosimilars (Hirudin)
    • Table 2.38 Candidate Biosimilars (Bevacizumab)
    • Table 2.39 Candidate Biosimilars (Enfuvirtide)
    • Table 2.40 Candidate Biosimilars (Glucagon)
    • Table 2.41 Candidate Biosimilars (Interleukin 11)152
    • Table 2.42 Candidate Biosimilars (Thyrotropin)
    • Table 2.43 Candidate Biosimilars (Abciximab)
    • Table 2.44 Candidate Biosimilars (Adalimumab)153
    • Table 2.45 Candidate Biosimilars (Alemtuzumab)
    • Table 2.46 Candidate Biosimilars (Anakinra)
    • Table 2.47 Candidate Biosimilars (Aprotinin)
    • Table 2.48 Candidate Biosimilars (Becaplermin)
    • Table 2.49 Candidate Biosimilars (Cetuximab)
    • Table 2.50 Candidate Biosimilars (Dnase)
    • Table 2.51 Candidate Biosimilars (Efalizumab)156
    • Table 2.52 Candidate Biosimilars (Eptifibatide)
    • Table 2.53 Candidate Biosimilars (Etanercept)
    • Table 2.54 Candidate Biosimilars (Gemtuzumab)
    • Table 2.55 Candidate Biosimilars (Infliximab)158
    • Table 2.56 Candidate Biosimilars (Natalizumab)
    • Table 2.57 Candidate Biosimilars (Nesiritide)
    • Table 2.58 Candidate Biosimilars (Omalizumab)
    • Table 2.59 Candidate Biosimilars (Palivizumab)
    • Table 2.60 Candidate Biosimilars (Rituximab)
    • Table 2.61 Candidate Biosimilars (Trastuzumab)
    • Table 3.1 Examples of Post-Translational Modifications
    • Table 3.2 Analytical Procedures Useful for Assessing The Equivalence of Biotechnological Products
    • Table 5.1 Leading Protein Drug Classes in 2006
    • Table 5.2 World Pharma Market by Therapeutic Category, 2006-2011
    • Table 5.3 World Pharma Market by Region, 2006-2011208
    • Table 5.4 Biopharmaceuticals Market by Application in 2006 and 2011
    • Table 5.5 Biopharmaceuticals Market by Company in 2006 and 2011210
    • Table 5.6 Biopharmaceuticals Market by Protein in 2006 and 2011
    • Table 5.7 Biosimilars Market by Protein in 2006 and 2011
    • Table 5.8 Biopharmaceuticals Market by Region in 2006 and 2011221
    • Table 5.9 Biosimilars Market by Region in 2006 and 2011
    • Table 6.1 Recently Published Cell-Free Protein Synthesis Patents and Applications