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  4. > Global & USA BioSimilar Market Analysis to 2021; Product Pipelines, Trends, Key Players, Regulations and Strategic Outlook

Biosimilars are highly-similar versions of biological drugs that are indicated for cancer, kidney disorders and a wide range of autoimmune diseases. Originator biologics are the most expensive drugs in the pharmaceutical industry and many of them cost nearly $100,000 per patient per year. These expensive biologics impose a heavy financial burden on patients and healthcare systems, limiting easy access and optimal care. Patent protection for some of the biologics has already expired and many more are to lose patent rights between now and 2020. This has given an opportunity to biotechnology companies to develop and market biosimilars with a cost benefit of about 20% to 30%.

In order to gain a slice of the $190 billion worth of biologic’s market, many biotechnology companies have ventured into the biosimilar sector bringing out less-expensive copies of reference biologics. Biosimilars have been in the E.U. market since 2006 and less-regulated markets such as China, India, and South Korea have a number of biosimilars in their domestic markets. After a long delay, finally, the FDA took a historic decision to approve the first biosimilar Zarxio from Sandoz on March 6, 2015. The coming years will witness the flooding of large number of biosimilars into the U.S., which happens to be the largest market for biopharmaceuticals.
This report provides a comprehensive overview of the size of biosimilars’ market, the segmentation of the market, key players and the vast potential of therapies that are in clinical trials. On total, about 44 biosimilars are available in the global market and currently the E.U. is the major market with 19 approved biosimilars in use. A significant number of biosimilars are available in the markets of China, India, South Korea and Latin America. Biosimilars from these emerging countries are approved by a less-stringent approval pathway and therefore, the commercialization of their products is mostly confined to the domestic markets. The report describes how the long-awaited FDA approval of Zarxio from Sandoz (biosimilar for Amgen’s Neupogen) in March 2015 is to transform the otherwise nascent market. The report includes:

- An overview of biosimilars that includes differences between biologics; biosimilars and generics, definition of biosimilars by different agencies, barriers in developing biosimilars, cost of developing biosimilars.
- A summary of regulatory pathways in various geographic regions.
- Development of biosimilars in Europe, China, India, South Korea, Latin America and the sudden spurt in the development of biosimilars in the U.S.
- A list of biosimilar developers in different geographic locations.
- An overview of biobetters that includes regulatory considerations, differences between biosimilars and biobetters, various biobetters that are in developmental stages, and the companies with the largest biobetter pipeline.
- An overview of approved biosimilars in the E.U., U.S., India, South Korea and Latin America.
- The market impact of biosimilars on their reference biologics such as Epogen, Humira, Remicade, Neupogen, Neulasta, Enbrel, Rituxan, Herceptin, Avastin and Lantus through 2021.
- The top ten biologics on the focus of biosimilar developers.
- The five major classes of biologics and their biosimilar counterparts.
- The current landscape of originators of biosimilars.
- Global market for biologics by region, through 2021.
- Global market for biologics by indication, through 2021.
- Global market for biologics by drug class, through 2021.
- Global market for biosimilars by region, through 2021.
- Global market for biosimilars by indication, through 2021.
- Global market for biosimilars by drug class, through 2021.
- Profiles of 95 biosimilar developers, their products in the market and their product pipeline.
- A newsletter in the appendix gives the latest news of biosimilar sector as of February 2015.

1.3 Key Questions Answered in This Report

- How do biologics, biosimilars and generics vary from each other?
- What are the different quality, safety and efficacy assessment tests for biosimilars?
- How much is being spent for developing a biosimilar molecule?
- How many years does a biosimilar take to reach the commercial market?
- How do regulatory pathways differ from region to region?
- What is the need for biosimilars?
- What are the different platforms for the development of biosimilars?
- What is the success rate in the development of a biosimilar when compared to a biologic and generic?
- What are the most attractive target biologics for the development of biosimilars?
- How many biosimilars are being developed for Avastin, Enbrel, Herceptin, Humira, Neulasta, and Rituxan, and what are they?
- How many biosimilar MAbs are being developed and what are they?
- How much can the U.S. save by the introduction of biosimilars, through 2024?
- Which companies are involved in developing biosimilar MAbs in South Korea?
- Who are the Indian players active in Indian biosimilar industry?
- What are the biosimilar drugs being developed by the Indian biosimilar developers?
- Name the biosimilars approved in the E.U., India, South Korea and Latin America?
- What is the current utilization rate of biosimilars in the E.U. countries?
- The biosimilars approved for use in Germany, Netherlands, U.K., South Korea, Japan, Latin America and India?
- How far the markets of Epogen, Humira, Remicade, Neupogen, Neulasta, Enbrel, Rituxan, Herceptin, Avastin and Lantus will be affected by the entry of biosimilar counterparts?
- What are the top ten biologics that have become the focus of biosimilar developers?
- What are the five major classes of biologics that have attracted the attention of biosimilar developers and what are their current market shares?
- What are the top ten biologic drugs from 2009 to 2014?
- Which biologic drugs dominated the U.S. market, between 2010 and 2014?
- How much is the Medicare Part B spending on biologics in the U.S.?
- What are the top-eight biologic drugs in the E.U. market?
- How many biologics maintain absolute dominance in the German market?
- What is the average cost of a biologic drug in the U.S.?
- How did the market for biosimilars perform between 2007 and 2014?
- How small is the market for biosimilars, when compared to that of biologics?
- What favorable signs are there in the industry to hope for an accelerated growth for biosimilars?
- What is the projected global and regional market for biosimilars from 2014 to 2021?
- What is the projected market for biosimilars by major drug classes from 2014 to 2021?
- Who are the market leaders in the biosimilar sector?
- What was the market for biosimilars in the major E.U. countries between 2007 and 2013?
- How much is the competition between biologics and biosimilars in the German market between 2007 and 2020?
- What is the potential market for biosimilars in the U.S., through 2020?

Table Of Contents

Global and USA BioSimilar Market Analysis to 2021; Product Pipelines, Trends, Key Players, Regulations and Strategic Outlook
1.0 Introduction 15
1.1 Executive Summary 15
1.2 Objectives of This Report 16
1.3 Key Questions Answered in This Report 17
2.0 Biosimilars: A Brief Overview 19
2.1 Biologic Drugs 19
2.1.1 Development of Biologics 20
2.1.2 Biologics vs. SMDs 20
2.2 Biosimilar Drugs 21
2.2.1 Definition of Biosimilars by The WHO, EMA and FDA 21
2.2.2 Quality Safety and Efficacy (QSE) Assessment of Biosimilars 22
2.2.3 Differences between Biosimilars and Biologics 23
2.2.4 Variations in Development Efforts for Biosimilars, Biologics and Generics 24
2.2.5 Barriers in Developing Identical Copies of Biologics 24
2.2.6 The Cost of Developing Biosimilars 25
2.2.7 Roadmap to a Biosimilar 25
2.2.8 The Emerging Role of Biosimilars 26
2.2.9 Different Names for Biosimilars 27
3.0 Regulations for Biosimilars: An Overview 28
3.1 Biosimilar Drug Registrations in Europe 28
3.1.1 Rules against Automatic Substitution of Biosimilars in E.U. Member States 29
3.1.2 Shareholders' Attitudes towards Biosimilars in Europe 29
3.2 Biosimilar Guidelines in China 30
3.3 Regulatory Pathway for the Approval of Biosimilars in India 31
3.4 Regulatory Pathway for the Approval of Biosimilars in the U.S. 32
3.4.1 U.S. Regulation on Interchangeability of Biosimilars 32
3.4.2 Extrapolation for Biosimilars in the U.S. 33
3.4.3 Totality of Evidence Approach for Biosimilar Approval by FDA 34
3.4.4 Evaluation of Immunogenicity in all Stages of Biosimilar Development 34
3.4.5 Timeline of U.S. Biosimilar Guideline Evolution, 2010-2015 35
3.5 Regulations Regarding the Use of Reference Products by Country 36
3.6 Regulations Regarding Extrapolation by Country 37
3.7 Regulations Regarding Clinical Studies by Country 37
3.8 Regulations Regarding Interchangeability by Country 38
3.9 Regulations Regarding Unique Naming by Country 39
4.0 Development of Biosimilars: An Overview 40
4.1 Unmet Need for Biosimilars 40
4.2 Stages in the Development of Biosimilars 40
4.2.1 Developing a Highly Similar Product 40
4.2.2 Confirming Biosimilarity 41
4.3 Biosimilar Development Stages 41
4.4 Capabilities Required for a Successful Biosimilar Developer 43
4.4.1 Manufacturing Capabilities 43
4.4.2 Clinical Development Experience and Regulatory Know-How 43
4.4.3 Customized Sales and Marketing Skills 43
4.4.4 Long-Term Biosimilar Strategy 43
4.4.5 Upfront Capital Investment 44
4.5 Types of Firms Participating in Biosimilar Development 44
4.6 Key Markets with Biosimilar Approval Pathways 45
4.7 Success Rates in the Development of Biosimilar Drugs 46
4.8 The Most Popular Biosimilar Targets 47
4.8.1 Total Number Biosimilars in Development for the Corresponding Biologics 47
4.8.1.1 Biosimilars in Development for Originator Avastin (Bevacizumab) 48
4.8.1.2 Biosimilars in Development for Originator Enbrel (Etanercept) 49
4.8.1.3 Biosimilars in Phase III Development for Herceptin (Trastuzumab) 49
4.8.1.4 Biosimilars in Development for Humira (Adalimumab) 50
4.8.1.5 Biosimilars in Development for Neulasta (Pegfilgrastim) 51
4.8.1.6 Biosimilars in Development for Rituxan (Rituximab) 52
4.9 Development of MAbs 53
4.9.1 Number of Biosimilar MAbs in the Pipeline 53
4.9.2 Development of Biosimilar MAbs in South Korea 54
4.9.3 Indian Players in Biosimilar Industry 55
4.9.3.1 Indian Biosimilar Pipeline 56
4.10 Biosimilar Map in Table Format 57
5.0 Biobetters: An Overview 60
5.1 Regulatory Considerations for Biobetters 60
5.2 General Differences between a Biosimilar and a Biobetter 61
5.3 Biobetters in Development 61
5.3.1 Development of Biobetters by Stage 62
5.4 Biobetter Development in South Korea 66
6.0 The Approved Biosimilars: An Overview 67
6.1 Authorized Biosimilars in Europe 67
6.1.1 Approved Biosimilars in Europe by Class 69
6.2 An Overview of Nineteen Biosimilars Approved in Europe 70
6.2.1 Abasaglar 70
6.2.2 Abseamed 71
6.2.3 Accofil 71
6.2.4 Bemfola 71
6.2.5 Binocrit 72
6.2.6 Biograstim 72
6.2.7 Epoetin Alfa Hexal 72
6.2.8 Filgrastim Hexal 73
6.2.9 Grastofil 73
6.2.10 Inflectra 73
6.2.11 Nivestim 74
6.2.12 Omnitrope 74
6.2.13 Ovaleap 74
6.2.14 Ratiograstim 74
6.2.15 Remsima 75
6.2.16 Retacrit 75
6.2.17 Silapo 75
6.2.18 Tevagrastim 76
6.2.19 Zarzio 76
6.3 Biosimilar Penetration in Europe 76
6.3.1 Biosimilar EPO Utilization in Europe 82
6.3.1.1 European Market Leaders for Biosimilar EPO 83
6.3.2 Biosimilar G-CSF in Europe 83
6.3.2.1 Penetration of G-CSF Biosimilars in Europe 84
6.3.2.2 The Three Major Biosimilar G-CSF Players in Europe 85
6.4 Price Differentials between Branded Neupogen, Eprex, Genotropin and their Biosimilar Counterparts in Europe 86
6.5 Biosimilars in Germany 88
6.6 Biosimilars Approved and Marketed in Netherlands 89
6.7 Biosimilars Available in U.K. for Myeloma 91
6.8 Biosimilars Approved and Marketed in South Korea 91
6.9 Biosimilars Approved and Marketed in Japan 92
6.10 Biosimilar MAbs in Latin America 92
6.11 Biosimilars Approved in India 94
7.0 The Impact of Biosimilars on Originators: An overview 97
7.1 Biosimilar Impact on Epogen 97
7.1.1 Available Biosimilars for Epogen 98
7.1.2 Cost of Epogen Treatment 98
7.2 Impact of Biosimilars on Humira 100
7.2.1 Biosimilars of Humira 100
7.3 Impact of Biosimilars on Remicade 101
7.3.1 Biosimilars for Remicade 102
7.4 Impact of Biosimilars on Neupogen 103
7.4.1 Biosimilars of Neupogen 104
7.5 The Impact of Biosimilars on Neulasta 105
7.5.1 Biosimilars for Neulasta 106
7.6 Impact of Biosimilars on Enbrel 106
7.6.1 Biosimilars to Enbrel 107
7.7 Impact of Biosimilars on Rituxan 108
7.7.1 Biosimilars of Rituxan 108
7.8 Impact of Biosimilars on Herceptin 109
7.8.1 Biosimilars of Herceptin 110
7.9 Impact of Biosimilars on Avastin 111
7.9.1 Biosimilars of Avastin 111
7.10 Impact of Biosimilars on Lantus 112
7.10.1 Biosimilars of Lantus 112
8.0 Top Ten Biologics on the Focus of Biosimilar Developers 114
8.1 Aranesp (Darbepoietin alfa) 114
8.2 Enbrel 115
8.3 Epogen/Procrit/Eprex/Erypo 116
8.4 Genotropin 118
8.5 Herceptin 118
8.6 Humira 119
8.7 Neulasta 120
8.8 Neupogen 122
8.9 Remicade 123
8.10 Rituxan 125
9.0 Five Major Classes of Originator Biologics and their Market Performance 127
9.1 Monoclonal Antibodies (MAbs) 127
9.1.1 Biosimilar MAbs in Pipeline 129
9.2 Tumor-Necrosis-Factor Alpha (TNF-alpha) 129
9.2.1 Biosimilar TNF-alpha Blockers 131
9.2.2 Biosimilar TNF-alpha Blockers in Development 132
9.3 Erythropoietin (EPO) 132
9.3.1 Biosimilars of EPO 134
9.4 Insulins 134
9.4.1 FDA-Approved Human Insulins 135
9.4.2 Biosimilar Insulins 137
9.5 Granulocyte-Colony Stimulating Factor (G-CSF) 137
9.5.1 Neupogen's Biosimilars 138
10.0 The Landscape of the Originators of Biosimilars 139
10.1 Domination of Biologics among the Top Ten Drugs in the U.S. 139
10.1.1 Medicare Spending on Biologics 141
10.1.2 U.S. Patent Expiry Dates for Best-Selling Biologics 142
10.2 Top Eight Biologics in European Market 142
10.2.1 Domination of Biologics in Germany 143
10.3 Distribution of Biopharmaceutical Companies 145
10.4 The Most Expensive Drugs 146
10.4.1 The Average Cost of Treatment with Biologic Drugs 147
10.5 Top 15 Biopharma Companies by Revenue 148
10.6 Projected Global Market for Top-Selling Biologics 150
10.7 Projected Sales of Top-Selling Biologics in the U.S. Market 152
10.8 Comparison of Treatment Costs of Biologics and Non-Biologics 154
11.0 A Brief Analysis of Market for Biologics 155
11.1 Global Market for Biologics: Sales and Growth Rate for the Past Six Years 155
11.2 Projected Market for Biologics by Geography 157
11.3 Top Ten Biopharmaceutical Companies 159
11.4 Top-Selling Biologics by Class 160
11.5 Five Biologics Least Affected by Biosimilars 160
11.5.1 Sustained Growth for Humira 161
11.5.2 Lantus Facing Imminent Competition 161
11.5.3 Higher Growth for Xarelto 162
11.5.4 Prenvar13: World's leading Vaccine 163
11.5.5 Eyelea: Surpassing the Predecessors 163
11.6 Five Biologics Showing Marginal declines in Sales 164
11.6.1 The Uncertain Revenue Base for Enbrel in the International Market 165
11.6.2 A Small Decline in Sales for Avastin 165
11.6.3 Difficult Patient Access to Rituxan 166
11.6.4 The Lining up of Biosimilars against Herceptin 167
12.0 Market for Biosimilars: An Overview 168
12.1 Past Seven Years of Market Performance by Biosimilars 168
12.2 Loss of Patent Protection for Biologics: The Major Driver of Biosimilars' Market 169
12.3 Relatively Small Size of Biosimilars' Market Compared to Biologics' 170
12.4 Favorable Signs for Increased Uptake of Biosimilars 171
12.5 Recent Events in Biosimilars' Market 171
12.6 Future of Biosimilars 172
12.7 Market for Biosimilars by Geography 172
12.8 Global Market for Biosimilars by Drug Class 174
12.9 Biosimilar Market Leaders 176
12.10 Distribution of Biosimilar Companies by Geography 177
12.10.1 The Largest Markets for Biosimilars in Europe 178
12.10.1.1 Biosimilars' Market in Germany 179
12.10.1.2 Norway's Efforts to Achieve Larger Biosimilar Uptake 180
12.11 The Market Potential for Biosimilars in the U.S. 180
12.11.1 Optimistic Predictions for the Growth of Biosimilars' Market in the U.S. 181
12.11.2 Viability of Biosimilars in the U.S. 182
12.11.3 Projected Savings with Biosimilars in the U.S. 183
12.11.4 Multiple Challenges for Biosimilars' Entry into the U.S. Market 183
12.11.5 Break-Even Analysis for Biosimilars in the U.S. 184
12.11.6 Biosimilars About to Enter the U.S. Market 184
12.12 SWOT Analysis 186
12.12.1 Strengths 186
12.12.2 Weaknesses 186
12.12.3 Opportunities 186
12.12.4 Threats 186
12.12.5 Market Drivers 186
12.12.6 Barriers 187
13.0 Selected Company Profiles 188
13.1 3SBio Inc. 188
13.1.1 Biosimilars from 3SBio 188
13.2 Abzena 188
13.3 Actavis plc 189
13.3.1 Actavis' Biosimilars 189
13.4 AET BioTech 189
13.4.1 Distribution Agreement for Adalimumab 189
13.4.2 Codevelopment of Adalimumab 189
13.5 Alvogen Inc. 190
13.6 Amega Biotech 190
13.7 Amgen Inc. 191
13.8 Anhui Anke Biotechnology (Group) Co., Ltd. 192
13.9 Apotex Inc. 192
13.9.1 Biosimilars from Apotex 192
13.10 Avesthagen Ltd. 193
13.10.1 Agreement with Elpen 193
13.10.2 Alliance with Kemwell Biopharma 193
13.11 Baxter International Inc. 193
13.11.1 Collaboration with Coherus 193
13.11.2 Collaboration with Momenta 194
13.12 Beijing Four Rings Biopharmaceutical Co., Ltd. 194
13.13 Bharat Biotech International Ltd. 195
13.13.1 Regen-D 150 195
13.13.2 Regen-D 60 195
13.14 Biocon Ltd. 196
13.14.1 Human Insulin 196
13.14.2 Insulin Glargine 196
13.14.3 Insulin Lispro 196
13.14.4 Insulin Aspart 198
13.14.5 Erythropoietin (EPO) 198
13.14.6 Filgrastim (GCSF) 198
13.14.7 Streptokinase 198
13.14.8 Monoclonal Antibodies (MAbs) 198
13.14.9 Contract Manufacturing 198
13.14.10 Research Services 199
13.15 Biogen Inc. 199
13.15.1 Joint Venture with Samsung 199
13.16 Bionovis SA 200
13.16.1 Bionovis' Product Pipeline 200
13.17 Biopartners GmbH 201
13.17.1 Somatropin 201
13.18 Biosidus S.A. 201
13.19 Bioton Spólka Akcyjna 202
13.19.1 Agreement with Medipolis 202
13.19.2 Agreement with Actavis 202
13.20 Bioviz Technologies Pvt., Ltd. 203
13.21 BioXpress Therapeutics SA 204
13.21.1 Future Programs 204
13.22 Biotechnol AS 205
13.22.1 Tb535 205
13.22.2 Tb434 205
13.23 Boehringer Ingelheim GmbH 205
13.23.1 Boehringer's Biosimilar Efforts 206
13.24 Bolder BioTechnology Inc. 206
13.25 Cadilla Pharmaceuticals Ltd 207
13.25.1 Exemptia 207
13.26 Celltrion Inc. 207
13.26.1 Remsima 207
13.26.2 Product Candidates 208
13.26.2.1 CT-P6 208
13.26.2.2 CT-P10 208
13.27 Cerbios-Pharma S.A 208
13.27.1 Biological Services 208
13.27.2 Biotechnology Services 208
13.27.3 Recombinant Urokinase 209
13.27.4 Recombinant G-CSF 209
13.28 Cipla Ltd. 209
13.28.1 Etacept 209
13.28.2 Actorise 209
13.29 CJSC Biocad 210
13.29.1 AcellBia 210
13.30 Ckd Bio Corp. 210
13.30.1 Phase I Study of Darbepoietin alfa Biosimilar 210
13.31 Claris Lifesciences Ltd. 211
13.31.1 Fegrast 211
13.32 Coherus Biosciences Inc. 211
13.32.1 The Pipeline 211
13.33 CT Arzneimittel GmbH 212
13.33.1 Biograstim 212
13.34 Dawoong Pharmaceutical Co. Ltd. 212
13.35 Dong-A Socio Holdings Co., Ltd. 212
13.36 Dr. Reddy's Laboratories Ltd. 213
13.36.1 Grafeel 213
13.36.2 Reditux 214
13.36.3 Cresp 214
13.36.4 Peg-Grafeel 214
13.37 Eli Lilly and Co. 214
13.37.1 Abasria 214
13.37.2 Basalgar 215
13.38 Emcure Pharmaceuticals Ltd. 215
13.38.1 Biosimilar for Herceptin 215
13.39 Epirus Biopharmaceuticals Inc. 215
13.39.1 Epirus' Programs 216
13.40 Finox AG 216
13.40.1 Bemfola r-FSH 216
13.41 Fujifilm Diosynth Biotechnologies 217
13.41.1 Joint Venture with Kyowa 217
13.42 Gan and Lee Pharmaceuticals Ltd. 217
13.43 GeneScience Pharmaceuticals Co., Ltd. 218
13.44 Genexine Co. Ltd. 219
13.45 Gennova Biopharmaceuticals Ltd. 219
13.45.1 Gennova's Biosimilar 220
13.46 Genor BioPharma Co., Ltd. 220
13.46.1 Genor's Pipeline 220
13.47 Glenmark Pharmaceuticals Ltd. 221
13.47.1 GBR 830 221
13.47.2 GBR 900 222
13.47.3 GBR 500 222
13.48 Glycotope GmbH 222
13.48.1 Glycotope's Pipeline 222
13.49 Green Cross Corp. 223
13.50 HanAll BioPharma Co., Ltd. 224
13.51 Hanwha Chemical Corp. 224
13.51.1 HD203 224
13.52 Harvest Moon Pharmaceuticals USA Inc. 225
13.52.1 Stable Cell Lines for Biosimilar Development 225
13.53 Hetero Drugs Ltd. 225
13.53.1 Darbepoetin alfa 226
13.54 Hexal AG 226
13.54.1 EPO-alfa Hexal 226
13.54.2 Filgrastim Hexal 226
13.55 Hospira Inc. 227
13.55.1 Retacrit 227
13.55.2 Nivestim 227
13.55.3 Inflectra 227
13.56 Innovent Biologics Inc. 228
13.56.1 IB1301 228
13.56.2 IB1302 228
13.56.3 IB1303 228
13.56.4 IB1305 228
13.56.5 IB1306 228
13.56.6 IB1308 228
13.57 Intas Pharmaceuticals Ltd. 229
13.58 ISU Abxis Co. Ltd. 230
13.58.1 Clotinab 230
13.58.2 ISU101 230
13.58.3 ISU302 and 303 230
13.58.4 ISU201 230
13.59 Kyowa Hakko Kirin Pharma Inc. 231
13.60 LG Life Sciences Co., Ltd. 232
13.60.1 Adalimumab Biosimilar 232
13.61 Lupin Ltd. 232
13.61.1 Lupin's Biosimilar 232
13.62 Mabion SA 233
13.62.1 Phase III for Rituximab Biosimilar 233
13.63 mAbxience S.A. 234
13.63.1 mAbxience's Biosimilars 234
13.64 MacroGenics Inc. 234
13.64.1 Collaboration with Janssen 234
13.64.2 Collaboration with Gilead 234
13.64.3 Collaboration with Boehringer Ingelheim 234
13.64.4 Collaboration with Green Cross 235
13.64.5 Collaboration with Takeda 235
13.64.6 Collaboration with Pfizer 235
13.64.7 MacroGenic's Pipeline 235
13.64.7.1 Margetuximab 235
13.64.7.2 MGA271 235
13.64.7.3 MGD006 235
13.64.7.4 MGD007 236
13.64.7.5 MGD001 236
13.64.7.6 MGD010 236
13.64.7.7 Teplizumab 236
13.65 Medice Arzneimittel Putter GmbH and Co. KG 236
13.65.1 Abseamed 236
13.66 Merck Serono 237
13.66.1 Serono's Biosimilar Programs 237
13.67 Merck and Co., Inc. 238
13.67.1 Biosimilar Development and Commercialization Agreement with Samsung Bioepis 238
13.68 MJ Biopharm Pvt. Ltd. 238
13.69 Mochida Pharmaceutical Co. Ltd. 239
13.69.1 LBEC0101 Trial 239
13.69.2 Collaboration wirh LG Life Sciences 239
13.70 Momenta Pharmaceuticals Inc. 240
13.70.1 Momenta's Biosimilars Program 240
13.71 Mycenax Biotech Inc. 240
13.71.1 TuNEX 241
13.72 Mylan NV 241
13.72.1 First Trastuzumab Biosimilar 241
13.72.2 Two U.S. Phase III Clinical Trials for Insulin Glargine 241
13.72.3 Partnership with Biocon 242
13.73 Nippon Kayaku Co. Ltd. 242
13.73.1 Nippon's Biosimilars 242
13.74 Oncobiologics Inc. 242
13.75 Pfizer Inc. 243
13.76 Pharma Praxis 244
13.77 PlantForm Corporation 244
13.78 Polpharma SA 245
13.78.1 Polpharma's Collaboration for Biosimilars 245
13.79 Probiomed S.A. de C.V. 245
13.80 Protalix BioTherapeutics Inc. 246
13.80.1 Biobetters from Protalix 246
13.80.1.1 PRX-102 246
13.80.1.2 Oral Anti-TNF 246
13.80.1.3 AIR DNase 246
13.80.1.4 Oral GCD 247
13.81 Ranbaxy Laboratories Ltd. (Sun Pharmaceutical Industries Ltd.) 247
13.81.1 Infimab 247
13.82 Ratiopharm GmbH 247
13.82.1 Ratiograstim 248
13.83 Reliance Life Sciences Pvt. Ltd. 248
13.83.1 ReliFeron 248
13.83.2 ReliPoietin 248
13.83.3 ReliGrast 249
13.83.4 MIRel 249
13.83.5 FostiRel 249
13.83.6 ReliBeta 249
13.83.7 ChorioRel 249
13.83.8 AbcixiRel 249
13.84 Samsung Bioepis Co., Ltd. 250
13.85 Sandoz Inc. 250
13.85.1 Sandoz's Biosimilars 250
13.85.2 Sandoz's Biosimilar Clinical Trials 251
13.86 Shanghai CP Guojian Pharmaceutical Co., Ltd. 251
13.87 Shantha Biotechnics Ltd. 252
13.87.1 Shanpoietin 252
13.89 Stada Arzneimittel AG 253
13.89.1 Biosimilars from Stada 253
13.90 Synthon BV 253
13.90.1 SYD985 254
13.90.2 Antibody Discovery Agreement 254
13.90.3 Global License Agreement for Biosimilar Trastuzumab 254
13.91 Teva Pharmaceutical Industries Ltd. 254
13.91.1 TevaGrastim 254
13.91.2 Ovaleap 254
13.92 USV Ltd. 255
13.92.1 PEG-Filgrastim 255
13.92.2 Teriparatide Injection 255
13.92.3 Somatropin 255
13.92.4 Filgrastim Injection 255
13.93 Wockhardt Ltd. 256
13.93.1 Glaritus 256
13.93.2 Wepox 256
13.94 Xencor Inc. 256
13.95 Xiamen Amoytop Biotech Co., Ltd. 257
13.95.1 Filgrastim (rHuG-CSF) 257
13.95.2 Oprelvekin (rHuIL-11) 258
13.95.3 Molgramostim (rHuGM-CSF) 258
14.0 Biosimilar Market Participants and their Focused Products 259

INDEX OF FIGURES

Figure 2.1: Size Comparison of Small Molecule Drugs (SMD) and Biologics 19
Figure 2.2: Reasons for the Differences in Biologics of the Same Class by Different Manufacturers 24
Figure 2.3: Roadmap to a Biosimilar 25
Figure 3.1: Scientific Justification to Support Extrapolation to Indications not clinically Stududied 33
Figure 3.2: Totality of Evidence Approach for Biosimilar Approval by FDA 34
Figure 3.3: Evaluation of Immunogenicity in all Stages of Biosimilar Development 35
Figure 4.1: Development Timeline for Biologics and Biosimilars Compared 41
Figure 4.2: Success Rates in the Development of Biosimilar Drugs 46
Figure 4.3: The Anticipated 2017 Peak in Revenues for Humira and Decline Thereafter 51
Figure 5.1: Number of Biobetters in Development by Stage 63
Figure 5.2: Number of Biobetters in Development by Region/Country 64
Figure 5.3: Companies with the Largest Pipeline of Biosimilars/Biobetters 65
Figure 6.1: Share of HGH, EPO and G-CSF Biosimilars Utilization in European Market 67
Figure 6.2: Approved Biosimilars in Europe by Class 70
Figure 6.3: Biosimilar Penetration in Austria, Belgium and Bulgaria 78
Figure 6.4: Biosimilar Penetration in Croatia, Czech Republic and Denmark 78
Figure 6.5: Biosimilar Penetration in Finland France and Germany 79
Figure 6.6: Biosimilar Penetration in Hungary, Ireland and Italy 79
Figure 6.7: Biosimilar Penetration in Norway, Poland and Portugal 80
Figure 6.8: Biosimilar Penetration in Romania, Slovakia and Slovenia 80
Figure 6.9: Biosimilar Penetration in Spain, Sweden, Switzerland and U.K. 81
Figure 6.10: Top Ten E.U. Countries in Biosimilar Penetration 81
Figure 6.11: The Steady Increase in Biosimilar EPO Utilization in Europe 82
Figure 6.12: The Four European Market Leaders for Biosimilar EPO 83
Figure 6.13: Volume Uptake of Biosimilar G-CSF in Standard Units vs. Daily G-CSF Available Market Products (%) in E.U. Countries 84
Figure 6.14: The Three Major Biosimilar G-CSF Players in Europe 85
Figure 6.15: Price Differential between Branded Neupogen and their Biosimilars in E.U. 5 87
Figure 6.16: Price Differential between Branded Eprex and Biosimilars in E.U. 5 87
Figure 6.17: Price Differential between Branded Genotropin and its Biosimilars in France, Germany, Spain and U.K. 88
Figure 7.1: Decline of Sales Revenue for Epogen due to Biosimilars, Through 2020 97
Figure 7.2: Epogen Treatment Cost for Three Major Indications 99
Figure 7.3: Revenue Generated by Epogen for Amgen, 2009-2014 99
Figure 7.4: Marginal Decline of Sales Revenues for Humira, Through 2020 100
Figure 7.5: Humira's Revenue Generation, 2010-2014 101
Figure 7.6: Decline of Sales Revenues for Remicade due to Biosimilars, Through 2020 102
Figure 7.7: Steady and Steep Decline of Revenues for Neupogen, Through 2020 103
Figure 7.8: Impact of Biosimilars on Neulasta's Sales, Through 2020 105
Figure 7.9: Marginal Decline in Sales Revenue for Enbrel due to Biosimilars, Through 2020 107
Figure 7.10: The Estimated Market for Rituxan after Biosimilar Competition, Through 2020 108
Figure 7.11: Impact of Biosimilars on Herceptin, Through 2020 110
Figure 7.12: Impact of Biosimilars on Avastin's Revenues, Through 2020 111
Figure 7.13: Impact of Biosimilars on Lantus, Through 2020 112
Figure 8.1: U.S. Sales Data for Aranesp 115
Figure 8.2: U.S. Sales Data for Enbrel 116
Figure 8.3: U.S. Sales Data for Epogen/Procrit/Eprex/Erypo 117
Figure 8.4: U.S. Sales Data for Herceptin 119
Figure 8.5: U.S. Sales Data for Humira 120
Figure 8.6: U.S. Sales Data for Neulasta 121
Figure 8.7: U.S. Sales Data for Neupogen 123
Figure 8.8: U.S. Sales Data for Remicade 124
Figure 8.9: U.S. Sales Data for Rituxan 126
Figure 9.1: Global Market for Monoclonal Antibodies 127
Figure 9.2: Global Market for TNF-alpha Blockers, Through 2021 131
Figure 9.3: Global Market for Originator Erythropoietin, Through 2021 133
Figure 9.4: Global Market for Human Insulins, Through 2021 135
Figure 10.1: The Growing Share (%) of Biologics, 2014-2023 140
Figure 10.2: Top Biologic Therapy Areas 144
Figure 10.3: Distribution of Biopharmaceutical Companies 146
Figure 10.4: The Daily Cost of Cerezyme, Kadyla, Humira, Branded Small Molecule Drugs and Generics in the U.S. 146
Figure 10.5: The Average Cost of Treatment with Biologic Drugs in the U.S. and Europe 147
Figure 10.6: Top 15 Biopharma Companies by Revenue 149
Figure 10.7: Global Market for Top-Selling Biologics, 2013-2020 151
Figure 10.8: Projected Sales of Top-Selling Biologics in the U.S. Market 153
Figure 11.1: Steadily-Growing Percent Share (%) of Biologics in Total Pharmaceutical Market 155
Figure 11.2: Global Market for Biologics: Sales and Growth Rate, 2008-2014 156
Figure 11.3: Percent Share of Geographical Markets for Biologics 157
Figure 11.4: Projected Global Markets for Biologics by Geography, Through 2021 158
Figure 11.5: Anticipated Decline for Originator Biologics' Share in the E.U., Through 2021 159
Figure 11.6: Top Ten Biopharmaceutical Companies, 2014 159
Figure 11.7: Top-Selling Biologics by Class 160
Figure 11.8: Global Market for Humira, Through 2021 161
Figure 11.9: Global Market for Lantus, Through 2021 162
Figure 11.10: Global Market for Xarelto, Throgh 2021 162
Figure 11.11: Global Market for Prenvar13, Through 2021 163
Figure 11.12: Global Market for Eylea, Throgh 2021 164
Figure 11.13: Global Market for Enbrel, Through 2021 165
Figure 11.14: Global Market for Avastin, Through 2021 166
Figure 11.15: Global Market for Rituxan, Through 2021 166
Figure 11.16: Global Market for Herceptin, Through 2021 167
Figure 12.1: Biosimilar Market Performance, 2007-2014 169
Figure 12.2: Biosimilars' Market Compared with Biologics', Through 2021 170
Figure 12.3: Market for Biosimilars by Geography, Through 2021 173
Figure 12.4: Global Market for Biosimilars by Drug Class, Through 2021 176
Figure 12.5: The Four Biosimilar Market Leaders and their Market Shares, 2008-2014 177
Figure 12.6: Distribution of Biosimilar Companies by Geography 178
Figure 12.7: Leading Biosimilar Markets in Europe, 2007-2013 178
Figure 12.8: Saving Potential of Biosimilars in Germany, Through 2020 179
Figure 12.9: Projected U.S. Biosimilar Market, Through 2020 181
Figure 12.10: Projected Savings with Biosimilars of 11 Specific Biologics in the U.S., 2012-2024 183

INDEX OF TABLES

Table 2.1: Differences between SMDs and Biologics 20
Table 2.2: Comparison between Biosimilars, Biologics and Generics 21
Table 2.3: Methods for QSE Assessment of Biosimilars 22
Table 2.4: Differences between Generics and Biosimilars 23
Table 2.5: Variations in Development Efforts for Biosimilars, Biologics and Generics 24
Table 2.6: E.U. and U.S. Approved Biosimilars and Their Therapeutic Areas 26
Table 2.7: Different Names for Biosimilars 27
Table 3.1: Biosimilar Drug Registration in Europe 28
Table 3.2: Rules against Automatic Substitution of Biosimilars in E.U. Member States 29
Table 3.3: Shareholders' Attitudes towards Biosimilars in E.U. 5 30
Table 3.4: Biosimilar Guidelines in China 31
Table 3.5: Regulatory Pathway for the Approval of Biosimilars in India 31
Table 3.6: Regulatory Pathway for the Approval of Biosimilars in the U.S. 32
Table 3.7: U.S. Regulation on Interchangeability of Biosimilars 33
Table 4.1: Strengths and Weaknesses of the Four Types of Biosimilar Firms 44
Table 4.2: Key Markets with Biosimilar Approval Pathways 45
Table 4.3: Success Rates in the Development of Biosimilar Drugs 46
Table 4.4: The Most Popular Biosimilar Targets 47
Table 4.5: Total Number Biosimilars in Development for the Corresponding Biologics 48
Table 4.6: Selected Biosimilars in Development for Avastin 48
Table 4.7: Biosimilars in Development for Originator Enbrel (Etanercept) 49
Table 4.8: Biosimilars in Phase III Development for Herceptin (Trastuzumab) 50
Table 4.9: Biosimilars in Development for Humira (Adalimumab) 50
Table 4.10: Biosimilars in Development for Neulasta (Pegfilgrastim) 52
Table 4.11: Biosimilars in Development for Rituxan (Rituximab) 52
Table 4.12: Selected Biosimilar Mabs Developers 53
Table 4.13: Number of Biosimilar MAbs in the Pipeline 54
Table 4.14: Development of Biosimilar MAbs in South Korea 55
Table 4.15: Indian Players in Biosimilar Industry 56
Table 4.16: Biosimilar Pipelines of Indian Players 57
Table 4.17: Biosimilar Developers from China 57
Table 4.18: Biosimilar Developers from Korea 58
Table 4.19: Biosimilar Developers from Europe 58
Table 4.20: Biosimilar Developers from the U.S. 58
Table 4.21: Biosimilar Developers from India 59
Table 4.22: Biosimilar Developers from South America 59
Table 4.23: Biosimilar Developers from Japan 59
Table 5.1: Differences between the Development of Biosimilars and Biobetters 60
Table 5.2: Selected Biobetters in Development 62
Table 5.3: Number of Biobetters in Development by Stage 63
Table 5.4: Number of Biobetters in Development by Region/Country 64
Table 5.5: Companies with the Largest Pipeline of Biosimilars/Biobetters 65
Table 5.6: Selected Biobetter Development in South Korea 66
Table 6.1: Biosimilars Approved in E.U. as of February 2015 68
Table 6.2: Approved Biosimilars in Europe by Class 70
Table 6.3: Biosimilar Penetration in Europe for HGH, EPO and G-CSF 77
Table 6.4: Approved Biosimilar G-CSF in Europe 84
Table 6.5: Price Differential between Branded Neupogen, Eprex, Genotropin and their Biosimilars 86
Table 6.6: Biosimilars Approved and Marketed in Germany 89
Table 6.7: Biosimilars Approved and Marketed in Netherlands 90
Table 6.8: Biosimilars Available in U.K. for Myeloma 91
Table 6.9: Biosimilars Approved and Marketed in South Korea 91
Table 6.10: Biosimilars Approved and Marketed in Japan 92
Table 6.11: Biosimilar MAbs Marketed in Latin America and others in Development 93
Table 6.12: Biosimilars Approved and Marketed in India as of January 2015 94
Table 7.1: Available Biosimilars for Epogen 98
Table 7.2: Biosimilars of AbbVie's Humira 101
Table 7.3: Biosimilars of Remicade 103
Table 7.4: Biosimilars of Neupogen 104
Table 7.5: Biosimilars of Neulasta 106
Table 7.6: Biosimilars to Enbrel 107
Table 7.7: Biosimilars of Rituxan 109
Table 7.8: Biosimilars of Herceptin 110
Table 7.9: Biosimilars of Avastin 112
Table 7.10: Biosimilars of Lantus 113
Table 8.1: Latest Available U.S. Sales Data for Aranesp 114
Table 8.2: U.S. Sales Data for Enbrel 116
Table 8.3: U.S. Sales Data for Epogen/Procrit/Eprex/Erypo 117
Table 8.4: U.S. Sales Data for Herceptin 118
Table 8.5: U.S. Sales Data for Humira 120
Table 8.6: U.S. Sales Data for Neulasta 121
Table 8.7: U.S. Sales Data for Neupogen 122
Table 8.8: U.S. Sales Data for Remicade 124
Table 8.9: U.S. Sales Data for Rituxan 125
Table 9.1: MAbs Approved and being Reviewed in the U.S. and Europe 128
Table 9.2: Biosimilar MAbs in the Pipeline 129
Table 9.3: Biosimilar TNF-Alpha Blockers Available in Less-Regulated Markets 131
Table 9.4: Biosimilar TNF-alpha Blockers in Development 132
Table 9.5: Biosimilars in Development or Approved 134
Table 9.6: FDA-Approved Human Insulins 136
Table 9.7: The Original G-CSF Products 137
Table 9.8: Biosimilars of Neupogen 138
Table 10.1: Biologics, Among the Top Ten Drugs, 2009-2014 139
Table 10.2: Domination of Biologics among the Top Ten Drugs in the U.S., 2010-2014 141
Table 10.3: Medicare Part B Spending on Biologics 141
Table 10.4: U.S. Patent Expiry Dates for Best-Selling Biologics 142
Table 10.5: Top Eight Biologics among the Top Ten Pharmaceuticals in Europe 143
Table 10.6: Domination of Biologics in Germany, 2009-2014 143
Table 10.7: Top Biologic Therapy Areas 144
Table 10.8: Distribution of Biopharmaceutical Companies 145
Table 10.9: The Average Cost of Treatment with Biologic Drugs in the U.S. and Europe 147
Table 10.10: Top 15 Biopharma Companies by Revenue 148
Table 10.11: Projected Global Market for Top-Selling Biologics, Through 2020 150
Table 10.12: Projected Sales of Top-Selling Biologics in the U.S. Market 152
Table 10.13: Comparison of Treatment Costs of Biologics and Non-Biologics 154
Table 11.1: Global Market for Biologics: Sales and Growth Rate, 2008-2014 156
Table 11.2 Projected Global Markets for Biologics by Geography, Through 2021 158
Table 11.3: Revenue Forecast for Humira, Lantus, Xarelto, Prenvar13 and Eylea, Through 2021 160
Table 11.4: Marginal Decline in Sales for Enbrel, Remicade, Avastin, Rituxan and Herceptin, Through 2021 164
Table 12.1: Biologics Losing Patent Protection, Through 2019 169
Table 12.2: Biosimilars' Market Compared with Biologics', Through 2021 170
Table 12.3: Market for Biosimilars by Geography, Through 2021 173
Table 12.4: Global Market for Biosimilars by Drug Class, Through 2021 175
Table 12.5: The Four Biosimilar Market Leaders and their Market Shares, 2008-2014 177
Table 12.6: Timeline for U.S. Patent Expiration of Branded Biologics 182
Table 12.7: Cost of Developing and Bringing a Biosimilar into the U.S. Market 182
Table 12.8: Break-Even Analysis for Biosimilars in the U.S., Under Three Different Scenarios 184
Table 12.9: Top Five Players Focused on Developing Biosimilars for the U.S. Market 185
Table 13.1: Amgen's Biosimilar Programs in Pivotal Trial (Phase III) 191
Table 13.2: Amgen's Other Biosimilar Products in Development 191
Table 13.3: Biocon's Biosimilar Pipeline 199
Table 13.4: Bionovis' Product Development Partnerships 200
Table 13.5: Binovis' Internal Product Development 200
Table 13.6: BioXpress' Biosimilar Pipeline 204
Table 13.7: Bolder's Product Pipeline 206
Table 13.8: Dong-A's Biomedicine Pipeline 213
Table 13.9: GeneScience's RandD Plan 218
Table 13.10: Genexine's hyFc Pipeline 219
Table 13.11: Genor's Pipeline 221
Table 13.12: Glenmark's Novel Drugs Pipeline 222
Table 13.13: Glycotope's Pipeline 223
Table 13.14: Green Cross' Biopharmaceutical Pipeline 223
Table13.15: HanAll's Pipeline 224
Table 13.16: Biologics/Biosimilars from Intas Pharmaceuticals 229
Table 13.17: Kyowa's Pipeline 231
Table 13.18: MJ Biopharm's Products and Products in Development 239
Table 13.19: Oncobiologic's Biosimilars Pipeline 243
Tabl 13.20: Pfizer's Biosimilar Pipeline 243
Table 13.21: Samsung's Biosimilar Pipeline 250
Table 13.22: Sandoz's Biosimilar Pipeline 251
Table 13.23: Xencor's Pipeline 257
Table 14.1: Representative Biosimilar Companies and Product Focus 259
Table 14.1: (Continued) 260
Table 14.1: (Continued) 261

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