Executive summary
Biologics market overview
US environment for biologics
European environment for biologics
Environment for biogenerics in the rest of the world
Key players in the biogenerics market
Chapter 1 Biologics market overview
Summary
Introduction
The importance of biogenerics
Biogenerics and the biotechnology industry
Biogenerics and the pharmaceutical Industry
Biogenerics and healthcare costs
The status of biogenerics remains uncertain
Biologics market overview
Biologics timeline
Unprecedented level of patent risk to biologic medicines
Biologic market dynamics
The threat to biotech revenue streams
Biologic technologies - relative risk
Chapter 2 US environment for biogenerics
Summary
Introduction
The environment for biogenerics in the US
Current progress on the introduction of biogenerics
Principal disagreements outlined in talks
Key issues of contention between the generics industry and the branded
biotechnology industry
The demonstration of bioequivalence
Immunogenicity
Labeling
Key factors impeding the availability of biogenerics 35
Changes in the manufacturing process determine the equivalence of
the end-product
Inconsistency in historical precedents set by the FDA
Lack of a regulatory framework for the approval of biogenerics
Organizational change
Factors that promote the early introduction of biogenerics
The economic cost of biologics
Increasing impetus for biogenerics in Congress
A timeline for the introduction of biogenerics in the US
Chapter 3 European environment for
biogenerics
Summary
Introduction
The environment for biogenerics in Europe
Progress towards the introduction of biogenerics in Europe
EU regulations on biogenerics
The issue of immunogenicity
Analysis of equivalence is highly subjective, with no firm guidelines
Lack of incentives may affect competitiveness of EU biogenerics market
Clinical studies will add to burden on biogenerics manufacturers
Political structures for the regulation of biogenerics may mean extended
timelines for generics approval
A timeline for the introduction of biogenerics in the EU
Chapter 4 Environment for biogenerics in
the rest of the world
Summary
Introduction
The environment for biogenerics in ROW
Regional Market Dynamics
Biogenerics in the ex-Tiger economies
Singapore
Background
Major biogeneric programs in Singapore
Taiwan
Background
Major biogeneric programs in Taiwan
South Korea
Background
Major biogenerics programs in South Korea
Biogenerics in Central and Eastern Europe
Biogenerics in China
Biogenerics in India
Chapter 5 Key players in the biogenerics
market
Summary
Product portfolios of major biogenerics companies
Partnership development in the biogenerics industry
Competitive profiles of major biogenerics companies
Index
Glossary
Glossary
List of Figures
Figure 1.1: Estimated number of biologic treatments approved in the US, 1982-2004
Figure 1.2: Estimated number of biologic treatments approved in the US by major indication, 2003
Figure 1.3: Major players in the biologic medicines market by revenue and sales growth, 2003 22
Figure 1.4: Estimated exposure to biogenerics by company, 2005-2010
Figure 1.5: Differences in relative risk between various classes of biotechnology drugs
Figure 2.6: The US environment for biogenerics, a PEST analysis
Figure 2.7: Simple biologic medicines are likely to be exempt from rigorous in vivo testing
Figure 2.8: Potential impact of increasing development of biotechnology-derived drugs on
prescription spending
Figure 2.9: Key political issues in both sides of the US biogenerics debate
Figure 2.10: Forecast roadmap for biogenerics legislation in the US
Figure 3.11: The European environment for biogenerics, a PEST analysis
Figure 3.12: Major steps towards the introduction of biogenerics in the EU
Figure 3.13: A timeline for the introduction of biogenerics in the EU
Figure 4.14: The environment for biogenerics in ROW, a PEST analysis
Figure 5.15: Biologic product portfolios of major biogenerics companies
Figure 5.16: Sample agreements between biogenerics manufacturers
Figure 5.17: Outline of key competitive attributes of major biogenerics companies
List of Tables
Table 1.1: Key biologic medicines, sales and estimated risk of generic competition, 2005-201019
Table 1.2: Key characteristics that determine level of risk from biogeneric competition in high
risk therapeutic areas
Table 2.3: Contrasts in positions on regulation of biogenerics between the generics lobby and the
biotechnology industry lobby, 2004
Table 2.4: Historic precedents in FDA rulings over approving biogenerics
Table 3.5: Issues in cataloguing immunogenicity under EU guidelines
Table 4.6: Overview of regional biogeneric market dynamics
Table 4.7: Major biogenerics projects believed to be active in Singapore
Table 4.8: Major biogenerics projects believed to be active in Taiwan
Table 4.9: Major biogenerics projects believed to be active in South Korea
Table 4.10: Major biogenerics projects believed to be active in the CEE region
Table 4.11: Major biogenerics projects believed to be active in China
