“Biosimilar/Follow-on Biologics Market Report & Forecast: A Focus on the US (2011-2020)”

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Report Description & Highlights

With sales worth US$ 57 Million in 2010, biosimilars are still far from their billion dollar sales potential

that most analysts believe they will generate. This market, however, unlike small molecule generics, is

expected to be more akin to a marathon than a sprint. IMARC Group, one of the world‘s leading

research and advisory firms, in its new report “Biosimilar/Follow-on Biologics Market Report &

Forecast: A Focus on the US (2011-2020)” finds that biosimilars in the US will soon represent a multi-

billion dollar market as they would be posing stiff competition to as many as twenty biological

molecules during 2011-2020.

Findings from the report suggest that the historical performance of Omnitrope cannot be taken as a

benchmark to gauge the potential of pipeline biosimilars as market acceptance for each biosimilar class

is expected to vary significantly from one another. The report expects that the competition between

branded biological drugs and their biosimilar counterparts would be more of a brand-brand competition

than a brand-generic competition. The high costs involved in the development and launch of biosimilars

are expected to limit the number of players in this market. As a result, erosions in price and volume

caused by biosimilars are likely to be lower compared to those created by small molecule generics.

IMARC‘s new report entitled “Biosimilar/Follow-on Biologics Market Report & Forecast: A Focus on

the US (2011-2020)” provides an analytical and statistical insight into the US biosimilar market. The

study, that has been undertaken using desk-based as well as qualitative primary research, provides and

draws upon analysis of six aspects of the US biosimilar market.

Key Aspects Analyzed:

Evaluating the Current Market Landscape of Biosimilars:

Identification of currently marketed biosimilars and their historical performance

Identifying the reasons for the slow uptake of currently marketed biosimilars

Analyzing historical data to formulate conclusions on the future growth and market trends of

biosimilars

Evaluating the Extent of Price, Sales and Volume Erosions Caused by Biosimilars:

Analyzing historical time series data on price, volume and sales erosion in the US & Europe

Analyzing previous models and assumptions on price and volume erosion caused by biosimilars

Evaluating and comparing price and volume erosion created by biosimilars vis-a-vis by small

molecule generics

Evaluating and comparing price, volume and sales erosion by biosimilars across various

biological classes

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Evaluating the Market Potential of Biosimilars Across Various Molecules:

Molecules Covered: Somatropin (Genotropin/Humatrope/Other HGH), Epoetin Alfa (Epogen/Eprex),

Filgrastim (Neupogen), Pegfilgrastim (Neulasta), Insulin Lispro (Humalog), Insulin Glargine (Lantus),

Insulin Detemir (Levemir), Interferon Beta-1A (Avonex), Interferon Beta-1A (Rebif), Interferon Beta-1B

(Betaferon), Bevacizumab (Avastin), Trastuzumab (Herceptin), Rituximab (Mabthera/Rituxan),

Cetuximab (Erbitux), Etanercept (Enbrel), Infliximab (Remicade), Adalimumab (Humira), Ranibizumab

(Lucentis), Omalizumab (Xolair) and Natalizumab (Tysabri).

Focus of the Analysis for Each Molecule:

Historical background and overview

Historical brand sales

Patent position

Competing products

Biosimilars in pipeline

Brand and biosimilar sales forecasts

Evaluating the Sales of Biosimilars across Various Indications:

Indications Covered: Immunology & Inflammation, Diabetes, Oncology, Blood Disorders and Growth

Deficiency

Focus of the Analysis for Each Indication:

Historical brand sales

Brand and biosimilar sales forecasts

Indication wise breakup of molecules

Evaluating the Biosimilar Competitive Landscape:

Identifying branded biological manufacturers that expect the highest amount of erosion from

biosimilars

Identifying biosimilar manufacturers and their pipelines

Understanding the Current Legislation on Biosimilars:

An insight into the Biologics Price Competition and Innovation Act

An insight into the key biosimilar issues that still remain unaddressed

Interchangeability and Substitutability

Data Exclusivity

Statutory provisions for dealing with patent litigations

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Table of Contents

1 Market Definitions & Research Methodology ............................................................................................... 13

2 Executive Summary ........................................................................................................................................ 15

3 The US Biosimilar Market Landscape ........................................................................................................... 21

4 US Biosimilar Market: Current Experience ................................................................................................... 24

4.1 The Performance of Growth Hormone Biosimilars Has Been Dismal So Far ............................................. 24

4.2 Pediatrics Represent the Prime Customer Base for Growth Hormones ..................................................... 25

4.3 Omnitrope Was Launched with an Inconvenient Delivery Device ............................................................... 25

4.4 Prescribing Patterns for Omnitrope ............................................................................................................ 26

4.5 Uptake is Likely to Increase with the Accumulation of Post-Market Safety Data ........................................ 26

5 US Biosimlar Market: How Much Price, Volume & Sales Erosion will Result ............................................ 28

5.1 Omnitrope Cannot be Taken as a Benchmark to Gauge the Performance of Other Biosimilars ................ 28

5.2 The European Uptake of ESA & GCSF Biosimilars Give Us a Very Positive Outlook for the US ............... 29

5.3 Models for Biosimilar Volume Erosion Across Various Biological Classes ................................................. 32

5.4 Models for Biosimilar Price Erosion Across Various Biological Classes ..................................................... 36

5.5 Models for Biosimilar Sales Erosion Across Various Biological Classes .................................................... 40

6 US Biosimilar Market: Current Trends & Forecast by Drug ........................................................................ 41

6.1 Growth Hormones ...................................................................................................................................... 44 6.1.1 Somatropin (Genotropin/Humatrope/Other HGH) .............................................................................. 44

6.1.1.1 Drug Overview ............................................................................................................................... 44 6.1.1.2 Current Brand & Biosimilar Sales .................................................................................................. 45 6.1.1.3 Brand & Biosimilar Forecast (2011-2020) ...................................................................................... 47

6.2 Erythropoiesis Stimulating Agents .............................................................................................................. 49 6.2.1 Epoetin Alfa (Epogen/Eprex) ............................................................................................................. 49

6.2.1.1 Drug Overview ............................................................................................................................... 49 6.2.1.2 Historical Brand Sales ................................................................................................................... 50 6.2.1.3 Brand & Biosimilar Forecast (2011-2020) ...................................................................................... 51

6.3 Granulocyte Colony Stimulating Factor ...................................................................................................... 54 6.3.1 Filgrastim (Neupogen) ....................................................................................................................... 54


6.3.2 Pegfilgrastim (Neulasta) ..................................................................................................................... 57 6.3.2.1 Drug Overview ............................................................................................................................... 57 6.3.2.2 Historical Brand Sales ................................................................................................................... 57 6.3.2.3 Brand & Biosimilar Forecast (2011-2020) ...................................................................................... 58

6.4 Insulin ......................................................................................................................................................... 60 6.4.1 Insulin Lispro (Humalog) .................................................................................................................... 60


6.4.2 Insulin Glargine (Lantus) .................................................................................................................... 63 6.4.2.1 Drug Overview ............................................................................................................................... 63 6.4.2.2 Historical Brand Sales ................................................................................................................... 64 6.4.2.3 Brand & Biosimilar Forecast (2011-2020) ...................................................................................... 64

6.4.3 Insulin Detemir (Levemir) ................................................................................................................... 66 6.4.3.1 Drug Overview ............................................................................................................................... 66 6.4.3.2 Historical Brand Sales ................................................................................................................... 66

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6.4.3.3 Brand & Biosimilar Forecast (2011-2020) ...................................................................................... 67

6.5 Interferons .................................................................................................................................................. 69 6.5.1 Interferon Beta-1A (Avonex) .............................................................................................................. 69


6.5.2 Interferon Beta-1A (Rebif) .................................................................................................................. 72 6.5.2.1 Drug Overview ............................................................................................................................... 72 6.5.2.2 Historical Biosimilar Sales ............................................................................................................. 72 6.5.2.3 Brand & Biosimilar Forecast (2011-2020) ...................................................................................... 73

6.5.3 Interferon Beta-1B (Betaferon/Betaseron) ......................................................................................... 75 6.5.3.1 Drug Overview ............................................................................................................................... 75 6.5.3.2 Historical Brand Sales ................................................................................................................... 75 6.5.3.3 Brand & Biosimilar Forecast (2011-2020) ...................................................................................... 76

6.6 TNF Alpha & Monoclonal Antibodies (Immunology & Inflammation) .......................................................... 78 6.6.1 Etanercept (Enbrel) ............................................................................................................................ 78


6.6.2 Infliximab (Remicade) ........................................................................................................................ 82 6.6.2.1 Drug Overview ............................................................................................................................... 82 6.6.2.2 Historical Brand Sales ................................................................................................................... 83 6.6.2.3 Brand & Biosimilar Forecast (2011-2020) ...................................................................................... 83

6.6.3 Adalimumab (Humira) ........................................................................................................................ 85 6.6.3.1 Drug Overview ............................................................................................................................... 85 6.6.3.2 Historical Brand Sales ................................................................................................................... 85 6.6.3.3 Brand & Biosimilar Forecast (2011-2020) ...................................................................................... 86

6.6.4 Ranibizumab (Lucentis) ..................................................................................................................... 88 6.6.4.1 Drug Overview ............................................................................................................................... 88 6.6.4.2 Historical Brand Sales ................................................................................................................... 88 6.6.4.3 Brand & Biosimilar Forecast (2011-2020) ...................................................................................... 89

6.6.5 Omalizumab (Xolair) .......................................................................................................................... 92 6.6.5.1 Drug Overview ............................................................................................................................... 92 6.6.5.2 Historical Brand Sales ................................................................................................................... 93 6.6.5.3 Brand & Biosimilar Forecast (2011-2020) ...................................................................................... 93

6.6.6 Natalizumab (Tysabri) ........................................................................................................................ 95 6.6.6.1 Drug Overview ............................................................................................................................... 95 6.6.6.2 Historical Brand Sales ................................................................................................................... 96 6.6.6.3 Brand & Biosimilar Forecast (2011-2020) ...................................................................................... 97

6.7 Monoclonal Antibodies (Oncology) ........................................................................................................... 100 6.7.1 Bevacizumab (Avastin) .................................................................................................................... 100

6.7.1.1 Drug Overview ............................................................................................................................. 100 6.7.1.2 Historical Brand Sales ................................................................................................................. 101 6.7.1.3 Brand & Biosimilar Forecast (2011-2020) .................................................................................... 102

6.7.2 Trastuzumab (Herceptin) ................................................................................................................. 104 6.7.2.1 Drug Overview ............................................................................................................................. 104 6.7.2.2 Historical Biosimilar Sales ........................................................................................................... 104 6.7.2.3 Brand & Biosimilar Forecast (2011-2020) .................................................................................... 105

6.7.3 Rituximab (Mabthera) ...................................................................................................................... 107 6.7.3.1 Drug Overview ............................................................................................................................. 107 6.7.3.2 Historical Biosimilar Sales ........................................................................................................... 107 6.7.3.3 Brand & Biosimilar Forecast (2011-2020) .................................................................................... 108

6.7.4 Cetuximab (Erbitux) ......................................................................................................................... 110 6.7.4.1 Drug Overview ............................................................................................................................. 110 6.7.4.2 Historical Brand Sales ................................................................................................................. 111 6.7.4.3 Brand & Biosimilar Forecast (2011-2020) .................................................................................... 111

7 US Biosimilar Market: Current Trends & Forecast by Indication .............................................................. 113

7.1 Immunology & Inflammation ..................................................................................................................... 116 7.1.1 Current Trends & Forecast .............................................................................................................. 116

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7.1.2 Biosimilar Sales Breakup by Molecule ............................................................................................. 117

7.2 Diabetes ................................................................................................................................................... 119 7.2.1 Current Trends & Forecast .............................................................................................................. 119 7.2.2 Biosimilar Sales Breakup by Molecule ............................................................................................. 120

7.3 Oncology .................................................................................................................................................. 121 7.3.1 Current Trends & Forecast .............................................................................................................. 121 7.3.2 Biosimilar Sales Breakup by Molecule ............................................................................................. 122

7.4 Blood Disorders ........................................................................................................................................ 124 7.4.1 Current Trends & Forecast .............................................................................................................. 124 7.4.2 Biosimilar Sales Breakup by Molecule ............................................................................................. 125

7.5 Growth Deficiency .................................................................................................................................... 127 7.5.1 Current Trends & Forecast .............................................................................................................. 127 7.5.2 Biosimilar Sales Breakup by Molecule ............................................................................................. 128

8 Competitive Landscape ................................................................................................................................ 129

8.1 Branded Manufacturers: Companies Facing the Highest Amount of Biosimilar Erosion .......................... 129

8.2 Biosimilar Manufacturers: Companies Gaining the Most From Biosimilar Launches ................................ 132

9 Biosimilar Legislation in the US................................................................................................................... 136

9.1 The Biologics Price Competition and Innovation Act: An Insight .............................................................. 136

9.2 Biosimilar Issues that Still Remain Unaddressed ..................................................................................... 139

9.3 Major Issues Impacting the Business Strategies of Biological Companies ............................................... 140 9.3.1 Interchangeability & Substitutability ................................................................................................. 140 9.3.2 Data Exclusivity ................................................................................................................................ 141 9.3.3 Patent Litigation ............................................................................................................................... 143

10 Key Company Profiles .................................................................................................................................. 145

10.1 Teva Pharmaceutical Industries Ltd.......................................................................................................... 145

10.2 Sandoz, Inc. .............................................................................................................................................. 146

10.3 Hospira, Inc. ............................................................................................................................................. 147

10.4 STADA Arzneimittel AG ............................................................................................................................ 148

10.5 Dr. Reddy's Laboratories Ltd. ................................................................................................................... 149

10.6 Celltrion, Inc. ............................................................................................................................................. 150

10.7 Bioexpress Therapeutics SA .................................................................................................................... 151

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List of Figures Figure 1-1: Model Used to Forecast Brand and Biosimilar Sales ................................................................................. 14

Figure 2-1: US: Executive Summary: Biosimilar Timeline: 2011-2020 ......................................................................... 15

Figure 3-1: US: Biosimilar Market (in Million US$), 2007-2010 .................................................................................... 21

Figure 3-2: US: Biosimilar Timeline: 2011-2020 ........................................................................................................... 22

Figure 3-3: US: Biosimilar Market Forecast (in Million US$), 2011-2020 ..................................................................... 23

Figure 4-1: US: Human Growth Hormone Market: Sales Share of Different Brands & Biosimilars (in %), 2007-2010 . 24

Figure 4-2: US: Human Growth Hormone Market: Brand & Biosimilar Patient Share (in %), 2007-2020 ..................... 27

Figure 5-1: US, Germany, France, Italy, Spain & UK: Somatropin Biosimilars: Patient Share (in %), 2007-2010 ...... 29

Figure 5-2: Germany, France, Italy, Spain & UK: Epoetin Alfa Biosimilars: Patient Share (in %), 2007-2010 ............ 30

Figure 5-3: US: Percentage of Physicians Expected to Prescribe ESA Biosimilars After They Have Been Launched,

(in %), 2010 .................................................................................................................................................................. 31

Figure 5-4: Germany, France, Italy, Spain & UK: Filgrastim Biosimilars: Patient Share (in %), 2008-2010 ................ 31

Figure 5-5: Average Generic Volume Erosion of Molecules Based-on Complex Drug Characteristics, (in %) ............. 33

Figure 5-6: Average Generic Volume Erosion Across Various Countries From Time Since First Generic Entry, (in %)

..................................................................................................................................................................................... 35

Figure 5-7: Average Generic Price Erosion of Molecules Based Upon Complex Drug Characteristics, (in %) ............ 38

Figure 5-8: Average Generic Price Erosion Across Various Countries From Time Since First Generic Entry ............. 38

Figure 5-9: Average Brand Price Erosion Across Various Countries From Time Since First Generic Entry ................ 39

Figure 6-1: US: Somatropin (Genotropin/Humatrope/Other HGH) Market: Brand & Biosimilar Sales Share (in %),

2007-2010 .................................................................................................................................................................... 46

Figure 6-2: US: Somatropin (Genotropin/Humatrope/Other HGH) Market: Share of Marketed Brands & Biosimilars (in

%), 2007-2010.............................................................................................................................................................. 47

Figure 6-3: US: Somatropin (Genotropin/Humatrope/Other HGH) Market Forecast: Brand & Biosimilar Sales Share (in

%), 2011-2020.............................................................................................................................................................. 48

Figure 6-4: US: Epoetin Alfa (Epogen/Eprex) Market: Share of Marketed Brands (in %), 2007-2010.......................... 51

Figure 6-5: US: Epoetin Alfa (Epogen/Eprex) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 . 53

Figure 6-6: US: Filgrastim (Neupogen) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ........... 56

Figure 6-7: US: Pegfilgrastim (Neulasta) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ......... 59

Figure 6-8: US: Insulin Lispro (Humalog) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ......... 62

Figure 6-9: US: Insulin Glargine (Lantus) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ......... 65

Figure 6-10: US: Insulin Detemir (Levemir) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ...... 68

Figure 6-11: US: Interferon Beta-1A (Avonex) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 . 71

Figure 6-12: US: Interferon Beta-1A (Rebif) Market: Brand & Biosimilar Sales Share (in %), 2011-2020 ................... 74

Figure 6-13: US: Interferon Beta-1B (Betaferon/Betaseron) Market Forecast: Brand & Biosimilar Sales Share (in %),

2011-2020 .................................................................................................................................................................... 77

Figure 6-14: US: Etanercept (Enbrel) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 .............. 81

Figure 6-15: US: Infliximab (Remicade) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ........... 84

Figure 6-16: US: Adalimumab (Humira) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 .......... 87

Figure 6-17: US: Ranibizumab (Lucentis) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ....... 91

Figure 6-18 : US: Omalizumab (Xolair) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ........... 94

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Figure 6-19: US: Natalizumab (Tysabri) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 .......... 99

Figure 6-20: US: Bevacizumab (Avastin) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ...... 103

Figure 6-21: US: Trastuzumab (Herceptin) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ... 106

Figure 6-22 : US: Rituximab (Mabthera) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ........ 109

Figure 6-23: US: Cetuximab (Erbitux) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ........... 112

Figure 7-1: US: Biosimilar Market Forecast: Share by Indication (in %), 2011-2020.................................................. 115

Figure 7-2: US: Immunology & Inflammation Market Forecast: Brand & Biosimilar Share (in %), 2011-2020 .......... 117

Figure 7-3: US: Immunology & Inflammation Market Forecast: Biosimilar Sales Breakup by Molecule (in %), 2011-

2020 ........................................................................................................................................................................... 118

Figure 7-4: US: Diabetes Market forecast: Brand & Biosimilar Share (in %), 2011-2020 ........................................... 119

Figure 7-5: US: Diabetes Market Forecast: Biosimilar Sales Breakup by Molecule (in %), 2011-2020 ..................... 120

Figure 7-6: US: Oncology Market Forecast: Brand & Biosimilar Share (in %), 2011-2020 ......................................... 122

Figure 7-7: US: Oncology Market Forecast: Biosimilar Sales Breakup by Molecule (in %), 2011-2020 .................... 123

Figure 7-8: US: Blood Disorder Market Forecast: Brand & Biosimilar Share (in %), 2011-2020 ................................ 125

Figure 7-9: US: Blood Disorder Biosimilar Market Forecast: Anemia & Neutropenia Sales (in %), 2011-2020 .......... 125

Figure 7-10: US: Blood Disorder Market Forecast: Biosimilar Sales Breakup by Molecule (in %), 2011-2020 ......... 126

Figure 7-11: US: Growth Deficiency Market: Brand & Biosimilar Share (in %), 2007-2010 ........................................ 127

Figure 7-12: US: Growth Deficiency Market Forecast: Brand & Biosimilar Share (in %), 2011-2020 ......................... 128

Figure 8-1: US: Innovator Company Brand Sales That Face Biosimilar Sales Erosion (in Million US$), 2010 & 2020

................................................................................................................................................................................... 131

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List of Tables

Table 1-1: US Biosimilar/Follow-On Biologics Market: Market Definition & Overview .................................................. 13

Table 2-1: US: Executive Summary: Major Biosimilar Launches ................................................................................. 16

Table 2-2: US: Executive Summary: Biosimilar Sales Forecast by Molecule (in Million US$), 2011-2020 ................... 18

Table 2-3: US: Executive Summary: Biosimilar Sales Forecast by Indication (in Million US$), 2011-2020 .................. 19

Table 3-1: US: Patent Expiries and Biosimilar Launch ................................................................................................. 22

Table 5-1: Biosimilar Vulnerability of Various Biopharmaceutical Classes ................................................................... 28

Table 5-2: Germany, France, Italy, Spain & UK: Epoetin Alfa Biosimilars: Patient Share (in %), 2007-2010 ............... 30

Table 5-3: Germany, France, Italy, Spain & UK: Filgrastim Biosimilars: Patient Share (in %), 2008-2010 ................. 32

Table 5-4: US: Various Studies & Assumptions for Biosimilar Volume Erosion ........................................................... 33

Table 5-5: US, Germany and UK: Biosimilar Volume Penetration by Molecule After 3 years from Launch (in %) ....... 36

Table 5-6: Various Studies & Assumptions for Biosimilar Price Erosion ...................................................................... 37

Table 5-7: US, Germany and UK: Biosimilar Sales Penetration by Molecule After 3 years from Launch (in %) .......... 40

Table 6-1: US: Biosimilar Sales by Molecule (in Million US$), 2007-2010 ................................................................... 41

Table 6-2: US: Biosimilar Sales Forecast by Molecule (in Million US$), 2011-2020 .................................................... 42

Table 6-3: US: Biosimilar Share Forecast by Molecule (in %), 2011-2020 ................................................................... 43

Table 6-4: US: Somatropin: Brand & Biosimilar Market Overview ............................................................................... 45

Table 6-5: US: Somatropin (Genotropin/Humatrope/Other HGH) Market: Brand & Biosimilar Sales/Patient Share,

2007-2010 .................................................................................................................................................................... 46

Table 6-6: US: Somatropin (Genotropin/Humatrope/Other HGH) Market: Sales of Marketed Brands & Biosimilars (in

Million US$), 2007-2010 ............................................................................................................................................... 46

Table 6-7: US: Somatropin (Genotropin/Humatrope/Other HGH) Market Forecast: Brand & Biosimilar Sales/Patient

Share, 2011-2020 ........................................................................................................................................................ 48

Table 6-8: US: Epoetin Alfa: Brand & Biosimilar Market Overview............................................................................... 49

Table 6-9: US: Epoetin Alfa (Epogen/Eprex) Market: Brand Sales (in Millions US$), 2007-2010 ................................ 50

Table 6-10: US: Epoetin Alfa (Epogen/Eprex) Market: Sales of Marketed Brands (in Million US$), 2007-2010 .......... 50

Table 6-11: US: Epoetin Alfa (Epogen/Eprex) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020

..................................................................................................................................................................................... 52

Table 6-12: US: Filgrastim: Brand & Biosimilar Market Overview ................................................................................ 54

Table 6-13: US: Filgrastim (Neupogen) Market: Brand Sales (in Millions US$), 2007-2010 ........................................ 55

Table 6-14: US: Filgrastim (Neupogen) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ......... 56

Table 6-15: US: Pegfilgrastim: Brand & Biosimilar Market Overview ........................................................................... 57

Table 6-16: US: Pegfilgrastim (Neulasta) Market: Brand Sales (in Millions US$), 2007-2010 ..................................... 58

Table 6-17: US: Pegfilgrastim (Neulasta) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ....... 58

Table 6-18: US: Insulin Lispro: Brand & Biosimilar Market Overview ........................................................................... 60

Table 6-19: US: Insulin Lispro (Humalog) Market: Brand Sales (in Millions US$), 2007-2010 ..................................... 61

Table 6-20: US: Insulin Lispro (Humalog) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ...... 62

Table 6-21: US: Insulin Glargine: Brand & Biosimilar Market Overview ....................................................................... 63

Table 6-22: US: Insulin Glargine (Lantus) Market: Brand Sales (in Millions US$), 2007-2010 ..................................... 64

Table 6-23: US: Insulin Glargine (Lantus) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ..... 65

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Table 6-24: US: Insulin Detemir: Brand & Biosimilar Market Overview ........................................................................ 66

Table 6-25: US: Insulin Detemir (Levemir) Market: Brand Sales (in Millions US$), 2007-2010 ................................... 67

Table 6-26: US: Insulin Detemir (Levemir) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 .... 68

Table 6-27: US: Interferon Beta-1A (Avonex): Brand & Biosimilar Market Overview ................................................... 69

Table 6-28: US: Interferon Beta-1A (Avonex) Market: Brand Sales (in Millions US$), 2007-2010 .............................. 70

Table 6-29: US: Interferon Beta-1A (Avonex) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 . 71

Table 6-30: US: Interferon Beta-1A (Rebif): Brand & Biosimilar Market Overview ....................................................... 72

Table 6-31: US: Interferon Beta-1A (Rebif) Market: Brand Sales (in Millions US$), 2007-2010 ................................... 73

Table 6-32: US: Interferon Beta-1A (Rebif) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 .... 73

Table 6-33: US: Interferon Beta-1B: Brand & Biosimilar Market Overview ................................................................... 75

Table 6-34: US: Interferon Beta-1B (Betaferon/Betaseron) Market: Brand Sales (in Millions US$), 2007-2010 ......... 76

Table 6-35: US: Interferon Beta-1B (Betaferon/Betaseron) Market Forecast: Brand & Biosimilar Sales/Patient Share,

2011-2020 .................................................................................................................................................................... 76

Table 6-36: US: Etanercept: Brand & Biosimilar Market Overview............................................................................... 79

Table 6-37: US: Etanercept (Enbrel) Market: Brand Sales (in Millions US$), 2007-2010 ............................................. 79

Table 6-38: US: Etanercept (Enbrel) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ............. 80

Table 6-39: US: Infliximab: Brand & Biosimilar Market Overview ................................................................................ 82

Table 6-40: US: Infliximab (Remicade) Market: Brand Sales (in Millions US$), 2007-2010 ......................................... 83

Table 6-41: US: Infliximab (Remicade) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ........... 84

Table 6-42: US: Adalimumab: Brand & Biosimilar Market Overview ............................................................................ 85

Table 6-43: US: Adalimumab (Humira) Market: Brand Sales (in Millions US$), 2007-2010 ........................................ 86

Table 6-44: US: Adalimumab (Humira) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 .......... 87

Table 6-45: US: Ranibizumab: Brand & Biosimilar Market Overview ........................................................................... 88

Table 6-46: US: Ranibizumab (Lucentis) Market: Brand Sales (in Million US$), 2007-2010 ........................................ 89

Table 6-47: US: Ranibizumab (Lucentis) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ....... 90

Table 6-48: US: Omalizumab: Brand & Biosimilar Market Overview ............................................................................ 92

Table 6-49: US: Omalizumab (Xolair) Market: Brand Sales (in Millions US$), 2007-2010 ........................................... 93

Table 6-50: US: Omalizumab (Xolair) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ............ 94

Table 6-51: US: Natalizumab: Brand & Biosimilar Market Overview ............................................................................ 95

Table 6-52: US: Natalizumab (Tysabri) Market: Brand Sales (in Millions US$), 2007-2010 ......................................... 96

Table 6-53: US: Natalizumab (Tysabri) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ......... 98

Table 6-54: US: Bevacizumab: Brand & Biosimilar Market Overview ........................................................................ 100

Table 6-55: US: Bevacizumab (Avastin) Market: Brand Sales (in Millions US$), 2007-2010 .................................... 101

Table 6-56: US: Bevacizumab (Avastin) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ....... 102

Table 6-57: US: Trastuzumab: Brand & Biosimilar Market Overview ......................................................................... 104

Table 6-58: US: Trastuzumab (Herceptin) Market: Brand Sales (in Millions US$), 2007-2010 ................................. 105

Table 6-59: US: Trastuzumab (Herceptin) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 .... 106

Table 6-60: US: Rituximab: Brand & Biosimilar Market Overview ............................................................................. 107

Table 6-61: US: Rituximab (Mabthera) Market: Brand Sales (in Millions US$), 2007-2010 ....................................... 108

Table 6-62: US: Rituximab (Mabthera) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ........ 109

Table 6-63: US: Cetuximab: Brand & Biosimilar Market Overview ............................................................................. 110

Table 6-64: US: Cetuximab (Erbitux) Market: Brand Sales (in Millions US$), 2007-2010 .......................................... 111

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Table 6-65: US: Cetuximab (Erbitux) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ........... 112

Table 7-1: US: Biosimilars Market: Indications Assigned for Various Molecules ........................................................ 113

Table 7-2: US: Biosimilars Market: Sales by Indication (in Million US$), 2007-2010.................................................. 114

Table 7-3: US: Biosimilar Market Forecast: Sales by Indication (in Million US$), 2011-2020 ................................... 114

Table 7-4: US: Immunology & Inflammation Market: Brand Sales (in Million US$), 2007-2010 ................................. 116

Table 7-5: US: Immunology & Inflammation Market Forecast: Brand & Biosimilar Sales (in Million US$), 2011-2020

................................................................................................................................................................................... 116

Table 7-6: US: Immunology & Inflammation Market Forecast: Biosimilar Sales Breakup by Molecule (in Million US$),

2011-2020 .................................................................................................................................................................. 118

Table 7-7: US: Diabetes Market: Brand Sales (in Million US$), 2007-2010 ............................................................... 119

Table 7-8: US: Diabetes Market Forecast: Brand & Biosimilar Sales (in Million US$), 2011-2020 ............................ 119

Table 7-9: US: Diabetes Market Forecast: Biosimilar Sales Breakup by Molecule (in Million US$), 2011-2020 ....... 120

Table 7-10: US: Oncology Market: Brand Sales (in Million US$), 2007-2010 ............................................................ 121

Table 7-11: US: Oncology Market Forecast: Brand & Biosimilar Sales (in Million US$), 2011-2020 ......................... 121

Table 7-12: US: Oncology Market Forecast: Biosimilar Sales Breakup by Molecule (in Million US$), 2011-2020 .... 122

Table 7-13 : US: Blood Disorder Market: Brand Sales (in Million US$), 2007-2010 ................................................... 124

Table 7-14 : US: Blood Disorder Market Forecast: Brand & Biosimilar Sales (in Million US$), 2011-2020 ................ 124

Table 7-15 : US: Blood Disorder Market Forecast: Biosimilar Sales Breakup by Molecule (in Million US$), 2011-2020

................................................................................................................................................................................... 126

Table 7-16 : US: Growth Deficiency Market: Brand & Biosimilar Sales (in Million US$), 2007-2010.......................... 127

Table 7-17 : US: Growth Deficiency Market Forecast: Brand & Biosimilar Sales (in Million US$), 2011-2020 ........... 127

Table 8-1: US: Innovator Companies Facing the Highest Amount of Biosimilar Sales Erosion (in Million US$), 2010,

2013, 2016 & 2020 ..................................................................................................................................................... 130

Table 8-2: Companies Developing Herceptin (Trastuzumab) Biosimilars .................................................................. 132

Table 8-3: Companies Developing Enbrel (Etanercept) Biosimilars ........................................................................... 133

Table 8-4: Companies Developing Remicade (Infliximab) Biosimilars ....................................................................... 133

Table 8-5: Companies Developing Mabthera (Rituximab) Biosimilars ....................................................................... 134

Table 8-6: Companies Developing Humira (Trastuzumab) Biosimilars ...................................................................... 134

Table 8-7: Companies Developing Other Biosimilars ................................................................................................. 135

Table 9-1: US: Overview of Biosimilar Legislations .................................................................................................... 136

Table 9-2: Comparison of Patent Protection and Data Exclusivity ............................................................................. 143

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