Table of Contents
Executive Summary
- Chapter 1: Biosimilars and the biosimilars industry
- Chapter 2: Factors affecting market access for biosimilars
- Chapter 3: The European position on biosimilars
- Chapter 4: The United States' position on biosimilars
- Chapter 5: Position on biosimilars: China and India
- Chapter 5: Position on biosimilars: other geographic regions
Chapter 1 Biosimilars and the biosimilars industry
- Summary
- Introduction and Overview
- Biotechnology in Healthcare and the Biotechnology Industry
- Biosimilars: terminology, definitions and nomenclature
- Biosimilars definitions and terminology
- Structure of the healthcare based Biotechnology Industry
- The pharmaceutical-biopharmaceutical relationship
- Emergence of the biopharmaceutical sector
- Biopharmaceutical sales by therapeutic area and leading companies
- Biopharmaceutical sales by therapeutic area
- Leading biopharmaceutical companies
- Characteristics and strategy of the biopharmaceutical industry
- Strategic alliances, joint ventures and mergers
- High technology and intellectual property issues
- High venture capital investment
- High risk and costs associated with drug development
- Challenges and major Issues
- The threat from biosimilars
- Erythropoietins (EPOs).
- Interferons
- Human Insulin and Insulins Analogues
- Monoclonal antibodies (MAb)
- Lack of regulatory guidelines and legislation controlling biosimilars
- Product complexity of biopharmaceuticals
- Differences in immunogenicity
- Differences in processing and manufacturing
Chapter 2 Factors affecting market access
- for biosimilars
- Summary
- Introduction
- Market dynamics
- Market drivers influencing biosimilars approval, use and uptake
- Emergence of biosimilars as patents of leading biopharmaceuticals
expire
- Biosimilars predicted to reduce global healthcare costs
- Advances in manufacturing and proving equivalence provide new impetus
to manufacturers
- Lower priced biosimilars enable greater patient coverage and market
penetration
- EMEA legislation relating to biosimilars sets standard for market
development of biosimilars in Europe
- Market restraints influencing biosimilars approval, use and uptake
- Political lobbying by branded companies
- Resistance to substitution of products from pharmacists, physicians
and patients
- R&D and commercialization of second generation biopharmaceuticals by
innovator companies
- Manufacturing issues related to bioequivalence and substitutability of
branded biopharmaceuticals
- Biosimilars: The cost and complexity of development
- Lack of legislation restricts growth of biosimilars in the United
States
- Determining the bioequivalence or essential similarity of biosimilars
- Proving equivalence of therapeutic proteins
- Glycosylation
- Mammalian cell culture processes
- Glyco-engineered yeast cell lines
- Proving equivalence of the end product
- Opinions from originator companies and supporting associations
- Opinions from generic manufacturers and supporting associations
- Demonstrating therapeutic equivalence
- Assays for confirming the presence of antibodies
- Assays for dissecting the specificity of antibodies
- Neutralization assays
Chapter 3 European position on biosimilars
- Summary
- European regulation on biosimilars
- EU legal and regulatory framework for biosimilar products
- Creation of the European Agency for the Evaluation of Medicinal Products
(EMEA)
- Directive 2001/83/EC
- Directive 2003/63/EC
- Directive 2004/27/EC
- Regulatory framework for biosimilars in Europe
- Principle European guidelines
- EU specific guidelines on biosimilars (quality & clinical and non
clinical issues)
- EU product specific guidelines on biosimilars
- Concerns over regulatory, clinical and marketing issues
- Prohibition of automatic substitution of biosimilars in European
countries
- National interpretations and implementation of the "Bolar Clause"
- Patient, pharmacist and physician acceptability of biosimilars
- Reimbursement of biosimilars in Europe
Chapter 4 United States position on biosimilars
- Summary
- Regulation and legislation affecting follow-on biologics in the US
- Historical background and current legislation in the US
- Historic legislative developments for biosimilars in the US
- Recent congressional legislation
- Access to Life-Saving Medicine Act (H.R. 1038/S.623)
- Patient Protection and Innovative Biologic Medicines Act (H.R. 1956)
- S.1695 The Biologics Price Competition and Innovation Act of 2007
- The Pathways for Biosimilars Act (H.R. 5629)
- The Federal Trade Commission reviews biosimilars and competition
(Notice Billing Code: 6750-01-S)
- The future outlook for biosimilars in the USA
Chapter 5 Position on biosimilars: China and India
- Summary
- China
- Healthcare regulation and legislation in China
- The Chinese biopharmaceutical and biosimilar industry
- Regulation and legislation of biologicals in China
- India
- Healthcare regulation and legislation in India
- Establishment of the Central Drug Authority (CDA)
- Improvements to the administration of biotechnologies in India
- The biopharmaceutical and biosimilar industry in India
- Regulation and legislation of biologicals in India
Chapter 6 Position on biosimilars: other geographic regions
- Summary
- Australia
- Regulation and legislation affecting biopharmaceuticals in Australia
- Regulatory approval process for medicines in Australia
- Regulatory approval process for biosimilars in Australia
- Canada
- Regulation and legislation affecting biopharmaceuticals in Canada
- Regulatory approval process for medicines in Canada
- Current position on subsequent entry biologics in Canada
- Interim regulatory status of sebs in Canada
- Japan
- Healthcare regulation and legislation in Japan
- Restructuring of principle regulatory agencies in Japan
- Major changes to pharmaceutical laws enacted April 2005
- The biopharmaceutical and biosimilar industry in Japan.
- Current position on follow-on biologicals (fobs) or biosimilars
Chapter 7 Appendix
- Methodology statement
- Primary Data and Information Gathering
- Secondary data and information gathering
- Market share analysis and market forecast predictions
- Definitions of Product-Life Cycle stages
- Glossary of abbreviations and acronyms
- Glossary of Terms
- Index
List of Figures
- Figure 1.1: Evolution of the biopharmaceutical corporation
- Figure 1.2: Comparison of global sales by biopharmaceutical class 2007
- Figure 1.3: Challenges and Issues Affecting the Biopharmaceutical Industry
- Figure 1.4: Predicted market share of multiple sclerosis drugs (2007-2017)
- Figure 1.5: Estimated last patent expiry dates of selected proteins
- Figure 2.6: Impact of second generation biopharmaceuticals on
erythropoietin market development (2000-2006)
- Figure 2.7: The process of determining therapeutic equivalence
- Figure 2.8: Analytical techniques used to physicochemically characterize
complex glycoproteins
- Figure 3.9: Structure of the EMEA
- Figure 3.10: Timeline of EU guidelines on biosimilars
- Figure 4.11: Timeline of US guidelines on follow-on-biologics
- Figure 5.12: Biopharmaceutical and pharmaceutical sales revenue in China
(2005)
List of Tables
- Table 1.1: Terminology used to describe generic biopharmaceuticals
- Table 1.2: Top 20 Pharmaceutical companies ranked by revenue (2007)
- Table 1.3: Top 10 Biopharmaceutical companies ranked by revenues (2007)
- Table 1.4: Biopharmaceutical sales by therapeutic area, 2007
- Table 1.5: Top 10 biopharmaceutical companies biopharmaceutical sales $m
(2003-2007) by ATC3, therapeutic products
- Table 1.6: Top 10 biopharmaceutical companies sales $m (2003-2007) by
ATC3, therapeutic products
- Table 1.7: Interferons on the market and patent expiries
- Table 1.8: Multiple sclerosis drugs on the market and patent expiries
- Table 1.9: Recombinant insulin products on the market and patent expiries
- Table 1.10: Summary of key structural data for selected therapeutic
protein products
- Table 1.11: Comparison of biopharmaceuticals versus chemical low molecular
weight drugs
- Table 2.12: Approved biosimilars EMEA and recommended authorizations
- Table 2.13: Productivity increases over the last 20 years in mammalian
cell culture
- Table 2.14: Physicochemical characterization methodology of
non-glycosylated proteins
- Table 3.15: Summary of biosimilar overarching guideline (EMEA/CHMP/437/04)
- Table 3.16: General EU guidelines on biosimilars
- Table 3.17: Summary of Biosimilar Quality Guideline (EMEA/CHMP/49348/05)
- Table 3.18: Summary of Biosimilar Non Clinical Guideline
(EMEA/CHMP/42832/05)
- Table 3.19: Summary of Biosimilars (non) Clinical Guideline Principles for
EMEA/CHMP/42832/05
- Table 3.20: EU product specific guidelines on biosimilars
- Table 3.21: EU revisions to product specific guidelines on biosimilars
- Table 5.22: Major biosimilars in China
- Table 5.23: Major biosimilar manufacturers in China
- Table 5.24: Top 60 Chinese-Owned Biopharmaceutical Companies (Part 1)
- Table 5.25: Top 60 Chinese-Owned Biopharmaceutical Companies (Part 2)
- Table 5.26: Top 60 Chinese-Owned Biopharmaceutical Companies (Part 3)
- Table 5.27: Major biosimilar manufactures based in India
- Table 5.28: Major Biosimilars and Manufacturers in India
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