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Biosimilars In Emerging Economies - Advanced Recombinant Technology Platforms And Low Cost Manufacturing Put India And China At A Strategic Advantage In Biosimilar Production

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Table of Contents

1 Table of Contents

1 Table of Contents 6

1.1 List of Tables 9

1.2 List of Figures 10

2 Introduction 11

3 Biosimilars in Emerging Economies – Market Overview 12

3.1 Biosimilars 12

3.1.1 Types of Biosimilars 12

3.2 Comparison of Biosimilars with Biologics and Generics 16

3.2.1 Structural Differences between Biologics, Generics and Biosimilars 17

3.3 Development of Biosimilars 18

3.4 Manufacturing of Biosimilars 19

3.4.1 Establishing a New Biosimilar Manufacturing Facility 19

3.5 Drivers and Restraints 20

3.5.1 Drivers 20

3.5.2 Restraints 21

3.6 Top 10 Biologics in 2011 22

3.7 Patent Expiries of Leading Biologics 23

3.8 Price Comparison of Biosimilars and Reference Products 23

4 Biosimilars in Emerging Economies – Market Characterization 24

4.1 Biosimilars Market Size and Forecast for Emerging Economies 24

4.2 Major Marketed Biosimilars in Emerging Economies 25

5 Biosimilars in Emerging Economies – India 28

5.1 Biosimilars Market Overview 28

5.2 Key Market and R&D Trends 29

5.2.1 Biocon's Deal to Commercialize Biosimilar Versions of Insulin Products with Pfizer Cancelled 29

5.3 Regulatory Landscape in India 29

5.3.1 Regulatory Framework for Biosimilars 29

5.4 Challenges and Opportunities 29

5.4.1 Challenges 29

5.4.2 Opportunities 30

5.5 Key Companies 31

5.5.1 Dr. Reddy's Laboratories (DRL) 31

5.5.2 Biocon 32

5.5.3 Intas Biopharmaceuticals (IBPL) 34

5.5.4 Reliance Life Sciences 35

5.5.5 Wockhardt 37

5.5.6 Lupin 38

5.5.7 Cipla 39

6 Biosimilars in Emerging Economies – China 41

6.1 Biosimilars Market Overview 41

6.1.1 Marketed Biosimilars in China 42

6.2 Regulatory Landscape in China 42

6.2.1 Regulatory Framework for Biosimilars 42

6.3 Challenges and Opportunities 43

6.3.1 Challenges 43

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