Abstract
As regulatory obstacles to biosimilars development have become increasingly
resolved, a growing number of opportunities have been created for generics
companies in the biopharmaceutical market, which is forecast to value in
excess of $135 billion by 2011. In response, the originators of
biopharmaceutical products are resorting to a range of defensive tactics,
including the reformulation of existing products to improve efficacy, the
implementation of more efficient delivery systems and the pursuit of
intellectual property battles. ' Negotiating the Emerging Biosimilars
Landscape' is a new report published by Business Insights that examines the
structure of the biopharmaceutical industry and the strategic approaches taken
to alleviate the threat posed by the biosimilar market. The key factors
affecting market access within the biosimilars market are assessed and the
latest issues surrounding bioequivalence are examined. This report also
provides a comprehensive review of the current legislative and regulatory
positions of key geographic regions in addition to evaluating their
anticipated future legislative changes and outcomes.
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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