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Global Biosimilars Industry
Date:5/19/2011

sis 56

Current & Future Analysis 56

Market Overview 56

US Establishes Drug Approval Pathway for Biosimilars 56

Overview of Various Sections of the Act 57

US Share to Increase in the Global Biosimilars Market 59

Biopharma Patent Expiries to Drive Biosimilars Growth 59

Patent Expiries of Select Biological Products in the US

(2007 and Beyond) 59

B.Market Analytics 60

Table 12: US Recent Past, Current & Future Analysis for

Biosimilars - Annual Sales Figures in US$ Million for Years

2008 through 2015 (includes corresponding Graph/Chart) 60

14. JAPAN 61

A.Market Analysis 61

Current & Future Analysis 61

B.Market Analytics 61

Table 13: Japanese Recent Past, Current & Future Analysis

for Biosimilars - Annual Sales Figures in US$ Million for

Years 2008 through 2015 (includes corresponding Graph/Chart) 61

15. EUROPE 62

A.Market Analysis 62

Current & Future Analysis 62

Market Overview 62

Biosimilar Approvals and Filings in Europe 63

A List of the Few of Withdrawn and Rejected Biosimilar

Applications in Europe 63

Biosimilars Regulatory Framework 63

Biosimilar Regulatory Timeline from Legislation to Approval

in the EU 64

Growth Drivers 64

Payers Eye Biosimilars to Curtail Costs 65

Challenges Ahead 65

Heavy Investment and Regulations 65

Complex Production Process 65

Biocapacity 65

Regional Issues 66

B.Market Analytics 66

Table 14: European Recent Past, Current & Future Analysis

for Biosimilars by Geographic Region - France, Germany, UK,

Spain and Rest of Europe Markets Independently Analyzed with

Annual Sales Figures in US$ Million for Years 2008 through

2015 (includes corresponding Graph/Chart) 66

Table 15: European 7-Year Perspective for Biosimilars by

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