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Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment

  • Published: Apr-2011
  • Report Code: GBIHC075MR
  • Report Format: pdf

Description

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Biosimilars Approval Pathways in the US and Europe – Introduction

2.1 GBI Research Report Guidance

3 Biosimilars Approval Pathways in the US and Europe – Market Overview

3.1 Overview of the Biopharmaceutical Industry

3.2 Biosimilars and their Significance

3.3 Comparison of Biosimilars with Generics

3.4 Biopharmaceutical Manufacturing Process

4 Biosimilars Approval Pathways in the US and Europe – Market Characterization

4.1 Global Biosimilar Market Size and Forecast

4.2 The US Biosimilars Market Size and Forecast

4.3 Europe Biosimilar Market Size and Forecast

4.4 Japan Biosimilars Market Size and Forecasts

4.5 Market Forecasts for Biosimilars

4.5.1 Human Growth Hormone (hGH) Biosimilars Markets

4.5.2 Erythropoietin (EPO) Biosimilars Markets

4.5.3 Granulocyte – Colony Stimulating Factor (G-CSF) Biosimilars Markets

4.6 Opportunity Analysis

4.6.1 Interferon alfa Biosimilars

4.6.2 Interferon beta Biosimilars

4.6.3 Insulin and Insulin Analogs Biosimilars

4.6.4 TNF alfa Inhibitor Biosimilars

4.6.5 Biosimilars for Monoclonal Antibodies against Cancer

5 Biosimilars Approval Pathways in the US and Europe – Industry Dynamics

5.1 Key Success Factors in the Biosimilar Industry

5.1.1 Long Term Strategy

5.1.2 Sound Financial Structure

5.1.3 Comprehensive Competitive Intelligence

5.1.4 Biomanufacturing Competencies

5.1.5 Clinical Development and Regulatory Expertise

5.1.6 Marketing, Sales and Distribution Capabilities

5.2 Participants in the Biosimilar Industry

5.3 Suppliers

5.3.1 Clinical Trial Capability Providers

5.3.2 Manufacturing Capacity Providers

5.3.3 Media and Reagents Providers

5.4 Innovators

5.5 Stakeholders

5.5.1 Regulators

5.5.2 Payers

5.5.3 Physicians

5.5.4 Patients and Patient Groups

6 Biosimilars Approval Pathways in the US and Europe – Drivers and Restraints

6.1 Drivers

6.1.1 Need to Cut Healthcare Costs in Developed Economies

6.1.2 Lower Development Costs and Regulatory Costs Compared to a New Biologic Drug

6.1.3 Lower Overall Cost of Treatment Using Biosimilar Drugs Compared to Biologics

6.1.4 Patent Expiry for Blockbuster Biologics

6.1.5 Increasing Uptake of Biologic Drugs

6.1.6 More Profitable than Generic Drugs

6.2 Restraints

6.2.1 Absence of Automatic Substitution

6.2.2 Higher Development and Manufacturing Costs Compared to Generics

6.2.3 High Entry Barriers

6.2.4 Threat from Second Generation Biologic Drugs

6.2.5 Patent Protection Around Biologic Drugs

7 Biosimilars Approval Pathways in the US and Europe – Regulatory Landscape

7.1 Regulatory Landscape in the US

7.1.1 Regulatory Framework for Biopharmaceutical Industry

7.1.2 Evolution of Regulatory Pathways for Biosimilars

7.1.3 BPCIA and the Pathway for Approval of Biosimilar Products

7.2 FDA’s Public Meeting on Biosimilars

7.2.1 Data requirement to Demonstrate Biosimilarity

7.2.2 The Standard for Interchangeability

7.2.3 Naming for Biosimilars

7.2.4 Extrapolation

7.2.5 Foreign Studies

7.2.6 Other Issues

7.2.7 Drivers and Barriers

7.3 Regulatory Landscape in Europe

7.3.1 Regulatory Framework for Biopharmaceutical Industry

7.3.2 Evolution of Regulatory Pathways for Biosimilars

7.3.3 Current Position on Biosimilars

7.3.4 The Bolar Type Provision

7.3.5 The Comparability Exercise

7.3.6 Biosimilars Approvals and Applications

7.3.7 EMEA Guidelines for Biosimilar mAb

7.3.8 Issues Facing the European Biosimilars Industry

7.3.9 Drivers for the European Biosimilars Market

7.3.10 Barriers for the European Biosimilars Market

7.3.11 Country Analysis – The UK

7.3.12 Country Analysis – Germany

7.3.13 Country Analysis – France

7.3.14 Country Analysis – Spain

7.3.15 Country Analysis – Italy

7.4 Regulatory Landscape in Japan

7.4.1 Regulatory Framework for Biopharmaceutical Industry

7.4.2 Evolution of Regulatory Pathways for Biosimilars

7.4.3 Current Position on Biosimilars

7.4.4 Drivers and Barriers

8 Biosimilars Approval Pathways in the US and Europe – Competitive Landscape

8.1 Profiles of Major Biosimilar Players

8.1.1 Sandoz

8.1.2 Teva Pharmaceuticals Ltd

8.1.3 Hospira Inc

8.1.4 Dr. Reddy’s Laboratories

8.1.5 Biocon Ltd

8.1.6 Biopartners

8.1.7 Watson Pharmaceuticals

8.1.8 STADA Arzneimittel AG

8.1.9 Reliance Life Sciences

8.1.10 Intas Biopharmaceuticals

8.1.11 Celltrion Inc.

8.1.12 3SBio Inc.

9 Biosimilars Approval Pathways in the US and Europe – Strategic Consolidations

9.1 M&A Deals

9.1.1 Pfizer–Biocon Deal

9.1.2 Teva Acquired Ratiopharm

9.1.3 Watson–Itero Deal

9.1.4 Biocon and Mylan Strategic Collaboration

9.1.5 Merck Acquired Insmed’s Follow-On Biologics for $130m

9.1.6 Teva and Lonza JV Targets Biosimilars

9.1.7 GTC Enters Follow-On-Biologic Founder Development Collaboration with Ag Research

9.1.8 Apotex–Intas Deal

9.1.9 Teva Acquires CoGenesys

9.2 R&D Licensing Deals

9.2.1 Innogene Seals Deal With CIMAB to Market Biosimilars

9.2.2 Abraxis Licenses Rights to Biosimilar from Indian Firm Biocon

10 Biosimilars Approval Pathways in the US and Europe – Appendix

10.1 Market Definitions

10.2 Abbreviations

10.3 Research Methodology

10.3.1 Coverage

10.3.2 Secondary Research

10.3.3 Primary Research

10.3.4 Expert Panel Validation

10.4 Contact Us

10.5 Sources

10.6 Disclaimer

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