Biosimilars: Global Markets

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Biosimilars: Global Markets

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REPORT SCOPE

INTRODUCTION

Since it is scientifically impossible to make identical copies of biologic drugs, biologic drugs often enjoy an extended market exclusivity period. However, the need to deal with rising healthcare costs has made it necessary to develop regulatory guidelines to analyze and approve copies of biologic drugs. The European Medicines Agency (EMA) has been the pioneer and the leading regulatory agency to establish guidelines for the approval of biosimilars. Several other regulatory agencies including the World Health Organization (WHO) have followed the EMA guidelines to a great extent in establishing their own guidelines.

The recent expiry of data protection or patents for the first group of biopharmaceuticals has opened up the possibility of developing biological products similar to these original products and to rely for licensing in part on the extensive knowledge gained with the originator products. Although copy versions of original biopharmaceuticals are already available in different parts of the world, there are no consistent regulatory processes applied worldwide for the market authorization of these products. The governments in semi- and unregulated markets are slowly adopting regulatory policies for improving the quality standards of these products. Unlike in the small molecule generic drugs sector, the biosimilar market is expected to grow at a relatively slow pace due to the safety concerns associated with them.

STUDY GOAL AND OBJECTIVES Europe

This BCC report provides an in-depth look at the demand for biosimilar drugs that have entered the market worldwide and forecasts the growth prospects for these products. It also analyses the biosimilar pipeline worldwide and includes their potential for getting approved and gaining significant market shares during the forecast period. Important product classes are considered separately while analyzing the market trends, and a bottoms-up approach is adopted for estimating the market size. Semi- and unregulated markets are also studied thoroughly and included in the report even though the products developed and marketed in these markets are not considered comparable in quality with the biosimilars marketed in regulated markets. Ignoring the potential of these products while studying the market dynamics is a mistake since key players in these markets are entering into tie-ups with partners with experience in regulated markets. Moreover, years of market experience in less regulated markets are likely to provide invaluable safety and efficacy insights, which will be an added advantage for these products.

Since regulation is the main factor that is driving and restraining the biosimilar market, regulatory framework in all the key markets is analyzed thoroughly. This report also analyses the future regulatory trends in all the key markets. Other aspects of the market analyzed in the report include pricing trends, technology advancements and their effects in affordability of biosimilars, key players in various regional markets and their capabilities, and the rising investments and the financial environment of the sector.

INTENDED AUDIENCE OF THE STUDY

Business strategies adopted by different categories of industry players including big pharmaceutical companies, biotech companies, start-up biotech and technology platform companies have been analyzed. These detailed analyses are targeted to help strategy developers and decision makers of biotech and pharmaceutical companies as well as other stakeholders including payers, venture capitalists, regulatory authorities, physicians and pharmacies. This is especially suitable for legislators involved in government policy development programs as well as law firms involved in IP matters of the healthcare industry. Technology trend analysis gives an overview of successful technologies, which is helpful for research managers in charge of project identification and development.

MARKET DEFINITION, SCOPE AND FORMAT

The market definition is important to consider in this report. There are several copies of biologic drugs sold for many years in semi- and unregulated markets before the establishment of biosimilar guidelines by the European Medicines Agency (EMA). The regulatory processes in these regions for the approval of these products are considerably less stringent compared to that of EMA. However, these companies are targeting regulated markets, and are adopting various strategies to enter highly regulated markets such as Europe and the U.S. Hence, the approach taken for this report is to include all the products for which EMA has already published guidelines for market authorization or for which guidelines are under development. The scope of this report includes the product segments such as somatropin, erythropoietin, Colony Stimulating Factors (CSFs), interferons, interleukins, insulin and insulin analogues, follicle stimulating hormones (FSHs), monoclonal antibodies (MAbs), and low molecular weight heparins (LMWH). It is often argued that LMWH is not essentially a biosimilar product since it is derived from dead tissues. However, considering the complexity of LMWH, EMA has developed specific guidelines for LMWH; hence, this is included as one of the product segment in this report. The global market size estimation includes the above mentioned product segments.

Both EMA and World Health Organization (WHO) exclude vaccines from consideration as biosimilars. The EMA guideline says: "Due to complexity and the likelihood that they cannot be thoroughly characterized at the molecular level, vaccines must be considered on a case-by-case basis." Besides vaccines, plasma-derived products and their recombinant analogues are also excluded from biosimilar guidelines by EMA due to their complex and variable physicochemical, biological and functional characteristics. Therefore, vaccines and blood products are not included as product segments in this report. Other biologic drug segments excluded in the market estimation of this report include streptokinase, hyaluronidase, etc., since biosimilar guidelines neither exist at present nor under development by EMA.

This report contains:

An overview of biosimilar product classes in various regions worldwide.

Biosimilar products approved by EMA.

A look at the biosimilar pipeline worldwide.

Detailed analysis of the emerging regulatory framework in regulated markets.

Comparison of biosimilar guidelines in Europe, the U.S., Japan, Canada, and the guidelines developed by WHO.

Detailed analysis of the market and key players in Europe and country-by-country analysis of key markets in Europe and the market forecasts for the region for various product classes

Detailed analysis of U.S. market regulation, key players and emerging trends.

Detailed analysis of the APAC market with analysis of key national markets (including Australia, Singapore, Korea, India, China and Japan), local players, investment trends and regulatory developments.

Detailed analysis of the rest of world (ROW) market size, trends, country analysis of promising markets (including Brazil, Russia, and Canada), regional players, and emerging regulatory and market trends.

Technology trends and patent analysis.

Profiles of over 70 key players.

Global and regional sales projections through 2016 for various product classes and regions.

INFORMATION SOURCES AND METHODOLOGY

Market figures are based on revenues at the manufacturer level and are projected at 2011 dollar values (i.e., inflation is not computed into the projection figures). Forecasts are based on the projections of the marketers, regulatory trends, patent expiry of innovator brands, strategies of innovator companies, concerns of various stakeholders including physicians and patients in each region, competitiveness of the market in terms of numbers of biosimilar products in each category, and marketing strategies of key players.

The information and data to prepare this study were derived from regulatory agencies, trade literature, patient support groups, annual reports of companies and industry-related databases. The analysis presented is based on an extensive survey of the biopharmaceutical industry as well as a detailed examination of published literature and reports obtained from regulatory authorities, medical research institutions, and national and world health organizations. Key information from the literature was used to obtain expert opinion and insights on commercial potential and market sizes from industry professionals, academic researchers and government agency spokespersons.

AUTHOR'S CREDENTIALS Bangalore, India TABLE OF CONTENTS

CHAPTER ONE: INTRODUCTION 1

STUDY GOAL AND OBJECTIVES 1

INTENDED AUDIENCE OF THE STUDY 2

MARKET DEFINITION, SCOPE AND FORMAT 3

INFORMATION SOURCES AND METHODOLOGY 4

AUTHOR'S CREDENTIALS 5

RELATED REPORTS FROM BCC RESEARCH 5

BCC ONLINE SERVICES 6

DISCLAIMER 6

CHAPTER TWO: SUMMARY 7

SUMMARY 7

SUMMARY TABLE GLOBAL DEMAND FOR BIOSIMILARS BY

VALUE, THROUGH 2016 ($ MILLIONS) 8

SUMMARY FIGURE GLOBAL BIOSIMILAR DEMAND BY VALUE

AND PRODUCT TYPE, 2011 (PERCENT) 9

CHAPTER THREE: MARKET OVERVIEW 10

THE TERMINOLOGY 10

TABLE 1 SIMILAR BIOLOGICAL PRODUCTS: TERMINOLOGIES AND

THEIR DEFINITIONS AS USED BY VARIOUS REGULATORY

AGENCIES 11

TABLE 1 (CONTINUED) 12

SMALL MOLECULE GENERICS VERSUS BIOSIMILARS 13

Small Molecule Generics … (Continued) 14

DISTINCT INTELLECTUAL PROPERTY ISSUES 15

TABLE 2 BIOSIMILARS VERSUS SMALL MOLECULE GENERICS 16

THE BIOSIMILAR OPPORTUNITY 16

TABLE 3 GLOBAL REVENUES OF LEADING

BIOPHARMACEUTICALS 17

TABLE 4 BIOLOGIC DRUGS LOSING PATENT PROTECTION

BETWEEN 2012 AND 2017 18

TABLE 5 POPULAR REFERENCE PRODUCTS TARGETED BY KEY

PLAYERS 18

VERY EXPENSIVE BIOLOGIC DRUGS DRIVING THE

DEMAND FOR BIOSIMILARS 18

TABLE 6 ANNUAL COSTS FOR THE TREATMENT USING SOME OF

THE BIOLOGIC DRUGS 19

TABLE 7 COST COMPARISON FOR RENAL DISEASE-ASSOCIATED

ANEMIA TREATMENT IN EUROPE 20

WORLDWIDE MARKETS FOR BIOSIMILARS—CURRENT STATUS 20

TABLE 8 BIOSIMILARS APPROVED BY EMA, 2011 21

TABLE 9 BIOSIMILARS APPROVED IN OTHER REGULATED

MARKETS—AUSTRALIA, CANADA, JAPAN, AND THE U S 21

TABLE 9 (CONTINUED) 22

TABLE 10 TOP PLAYERS IN THE GLOBAL BIOSIMILAR MARKET 23

MARKET SIZE AND GROWTH TRENDS OF GLOBAL

BIOSIMILAR MARKET 23

Market Size and Growth Trends …(Continued) 24

TABLE 11 THE GLOBAL AND REGIONAL BIOSIMILAR MARKETS

BY VALUE THROUGH 2016 ($ MILLIONS) 25

TABLE 12 THE GLOBAL MARKETS FOR VARIOUS PRODUCT

CLASSES OF BIOSIMILARS BY VALUE, THROUGH 2016 ($

MILLIONS) 26

THE EVOLVING BIOSIMILAR REGULATORY LANDSCAPE 27

UNRESOLVED SCIENTIFIC AND REGULATORY

CONCERNS 28

TABLE 13 SCIENTIFIC AND REGULATORY CONCERNS RELATED

TO BIOSIMILAR AUTHORIZATION 28

TABLE 13 (CONTINUED) 29

Naming/ Nomenclature 29

Interchangeability 30

Traceability 31

Lack of Access to Reference Product 31

CLINICAL CONCERNS 32

TABLE 14 COMMON BIOLOGICS AND THEIR IMMUNOGENICITY

POTENTIALS 33

DATA EXCLUSIVITY 34

TABLE 15 DATA EXCLUSIVITY PERIODS OF REFERENCE FOR

BIOLOGIC DRUGS IN EU, U S AND JAPAN 35

AN OVERVIEW OF THE CURRENT REGULATORY PRACTICES IN

U S , EUROPE, AND SEMI-REGULATED MARKETS 36

EUROPE 36

Europe (Continued) 37

THE U S 38

TABLE 16 BIOSIMILAR REGULATION: CURRENT STATUS IN EU

AND U S 39

TABLE 16 (CONTINUED) 40

TABLE 16 (CONTINUED) 41

OTHER MARKETS 41

TABLE 17 BIOSIMILAR GUIDELINES FEATURES ADOPTED BY

JAPAN, CANADA AND WHO 42

TABLE 17 (CONTINUED) 43

TABLE 17 (CONTINUED) 44

PARTNERSHIPS, COLLABORATIONS, LICENSING AND

ACQUISITIONS DRIVING BIOSIMILAR DEVELOPMENT 45

TABLE 18 BIOSIMILAR TARGETED BUSINESS DEALS SIGNED IN

2011 45

TABLE 18 (CONTINUED) 46

TABLE 18 (CONTINUED) 47

BIG PHARMA KEEN TO TAP THE BIOSIMILAR OPPORTUNITY 47

TABLE 19 RECENT BIOSIMILAR DEALS MADE BY

MULTINATIONAL PHARMACEUTICAL COMPANIES 48

TABLE 19 (CONTINUED) 49

UNUSUAL ENTRANTS FROM ELECTRONIC AND OTHER

INDUSTRIES 49

KEY CHALLENGES OF THE GLOBAL BIOSIMILAR

MARKET 49

TABLE 20 KEY CHALLENGES OF THE GLOBAL BIOSIMILAR

MARKET 50

Hesitation of Physicians to Switch to Biosimilars 50

Limitations of CMC Comparability Exercise in

Demonstrating Biosimilarity 51

Prohibition to Automatic Substitution by Pharmacists in

Key Markets 52

Uncertainty Regarding Extrapolation of Indications

Limits Access to Potential Patient Population 52

Low-Price Discounts Ineffective to Shift the Focus From

Innovator Brands to Biosimilars 53

Entry of Low Quality Biosimilars Affects the Market

Perception 53

TABLE 21 KEY CONCERNS OF CHMP REGARDING THE INSULIN

BIOSIMILAR APPLICATIONS BY MARVEL LIFE SCIENCES 54

Regulatory Guidelines Regarding Extrapolation of

Indications are Vague 55

Long Term Deals Between Big Pharma and Customers

May Impact Biosimilar Opportunity 55

Emerging Interest in Biobetters Can Impact the Market

Share of Biosimilars 55

Data Exclusivity Period of Innovator Biologic Drugs

Impact the Profitability of Biosimilars 56

High Development and Production Costs Leading to High

Prices and Low Savings from Biosimilars 56

The Lack of Consensus Between Stakeholders Slows

Down the Regulatory Process Development 57

PRICING OF BIOSIMILARS 57

TABLE 22 FACTORS INFLUENCING THE PRICING STRATEGIES

FOR BIOSIMILARS 58

The Role of Payers 59

THE RICH BIOSIMILAR PIPELINE 59

TABLE 23 BIOSIMILAR PRODUCTS IN ADVANCED STAGES OF

DEVELOPMENT WORLDWIDE 59

TABLE 23 (CONTINUED) 60

CHAPTER FOUR: BIOSIMILAR MARKETS IN EUROPE 61

TABLE 24 DETAILS OF BIOSIMILAR APPROVALS IN THE EU 61

TABLE 24 (CONTINUED) 62

LEGISLATION AND POLICIES IN THE EU AND MEMBER STATES 62

TABLE 25 MAIN BIOSIMILAR REGULATORY TEXTS IN EU 63

TABLE 25 (CONTINUED) 64

TABLE 26 BIOSIMILAR GUIDELINES PUBLISHED IN THE EU 65

TABLE 26 (CONTINUED) 66

TABLE 26 (CONTINUED) 67

REFERENCE PRODUCTS AND THEIR MARKET EXCLUSIVITY

PERIODS IN THE EU 67

TABLE 27 NUMBER OF YEARS OF EFFECTIVE MARKET

EXCLUSIVITY ENJOYED BY SOME OF THE INNOVATOR BRANDS

ACROSS EU5 68

THE MARKET AUTHORIZATION PROCESS OF BIOSIMILARS IN

THE EU 68

TABLE 28 SUMMARY OF THE MARKET AUTHORIZATION PROCESS

OF BIOSIMILARS IN THE EU 69

TABLE 28 (CONTINUED) 70

AVAILABILITY OF BIOSIMILARS IN MEMBER STATES 70

TABLE 29 LAUNCHING DATES OF BIOSIMILAR BRANDS ACROSS

VARIOUS EU MEMBER STATES 71

THE BIOSIMILAR MARKET IN EU 72

TABLE 30 THE BIOSIMILAR MARKET IN THE EU BY VALUE,

THROUGH 2016 ($ MILLIONS) 72

TABLE 31 THE RISING MARKET SHARE OF BIOSIMILARS IN THE

EU MARKET, 2007-2011 73

TABLE 32 THE MARKET PENETRATION OF SOMATROPIN,

ERYTHROPOIETIN AND FILGRASTIM BIOSIMILARS ACROSS

EU5, 2011 (%) 74

TABLE 33 BIOSIMILAR ACCEPTANCE IN SELECTED NON-EU5

MEMBER STATES (%) 74

THE PUZZLING SLOW MARKET GROWTH OF

BIOSIMILARS IN EUROPE 74

MOLECULE TYPE AND INDICATIONS WILL PLAY KEY

ROLES IN THE BIOSIMILAR UPTAKE IN EUROPE 75

HEALTH CONCERNS REGARDING INTERCHANGEABILITY – A

KEY CHALLENGE 75

TABLE 34 POLICIES REGARDING AUTOMATIC SUBSTITUTION OF

BIOSIMILARS ACROSS THE EU 76

COMPLEXITY ASSOCIATED WITH BIOSIMILAR PRODUCTION IS

LEADING TO SUPPLY SHORTAGES IN EUROPE 76

ABBREVIATION OF REGULATORY ASSESSMENTS OF

BIOSIMILARS 77

THE PRICING AND REIMBURSEMENT (P&R) POLICIES ACROSS

THE MEMBER STATES 77

TABLE 35 POTENTIAL INFLUENCE OF THE PRICE APPROVAL

DELAYS ON LAUNCHING PRIORITIES BY BIOSIMILAR

COMPANIES IN SELECTED EU MEMBER STATES 78

THE REFERENCE PRICING SYSTEM (RPS) 79

TABLE 36 REFERENCE PRICING SYSTEMS IMPLEMENTED IN EU

MEMBER STATES 80

RPS versus Health Technology Assessment (HTA) 81

TABLE 37 COMPARISON OF THE POLICIES INFLUENCING THE

P&R SCENARIO OF BIOSIMILARS ACROSS EU5 82

TABLE 38 PHARMACEUTICAL P&R POLICIES AND PROCESSES IN

SELECTED NON-EU5 MEMBER STATES 83

TABLE 38 (CONTINUED) 84

TABLE 38 (CONTINUED) 85

TABLE 38 (CONTINUED) 86

Biosimilar Price and Market Competition 86

TABLE 39 THE IMPACT OF EPO BIOSIMILAR ENTRY IN GERMANY 86

Uptake of Biosimilars Faster in the Retail Sector 87

GERMANY 87

TABLE 40 DRIVERS OF THE BIOSIMILAR MARKET IN GERMANY 88

STRONG GOVERNMENT SUPPORT 88

High Payer Pressures 88

Fixed Reference Price (FRP) System 88

Pre-Defined Regional Quotas 89

TABLE 41 REGIONAL PRESCRIPTION QUOTAS FOR EPO

BIOSIMILARS IN GERMANY (%) 89

Generic Friendly Market 89

FAVORABLE APPROACH BY PHYSICIANS 90

REPRESENTATION BY REPUTED COMPANIES 90

THE REGULATORY SCENARIO IN GERMANY 90

FRANCE 91

REGULATORY STATUS OF BIOSIMILARS AND

REIMBURSEMENT PROCESSES IN FRANCE 92

TABLE 42 REGULATORY AUTHORITIES/ORGANIZATIONS

INVOLVED IN MARKET AUTHORIZATION OF MEDICINES IN

FRANCE 92

TABLE 42 (CONTINUED) 93

The Rising Acceptance of Generic Drugs in France 93

The Price Cuts Make Biosimilar Prices Equivalent to

Those of the Originators 94

Automatic Substitution by Pharmacists is Banned in the

Case of Biosimilars 94

HIGH LEVELS OF BRAND LOYALTY AND LOW LEVELS OF

ACCEPTABILITY BY PHYSICIANS 94

SPAIN 95

THE REGULATORY ENVIRONMENT IN SPAIN 95

Before 2010 95

The Royal Decree on the Rationalization of Drug

Expenditure and Other Regulatory Measures

Introduced in 2010 96

Additional Regulatory Measures Implemented in 2011 96

Low Prices Affect Drug Availability 97

THE ROLE OF AUTONOMOUS REGIONS IN SPAIN 97

SPECIFIC MEASURES TARGETING THE DEMAND FOR

BIOSIMILARS 97

ITALY 98

PHARMACEUTICAL REGULATORY STRUCTURE IN ITALY 98

TABLE 43 ORGANIZATIONS AND COMMITTEES INVOLVED IN THE

PHARMACEUTICAL REGULATION PROCESSES IN ITALY 99

TABLE 43 (CONTINUED) 100

P&R Procedures in Italy 100

TABLE 44 NEGOTIATED PRICE REDUCTIONS FOR BIOSIMILARS

COMMERCIALIZED IN ITALY 101

Italian Regulation Does Not Favor Substitutability of

Biosimilars 101

AVAILABILITY OF BIOSIMILARS IN ITALY 101

TABLE 45 BIOSIMILARS AVAILABLE IN ITALY 102

THE IMPACT OF THE AUSTERITY MEASURES BY THE

GOVERNMENT ON THE BIOSIMILAR MARKET 102

TABLE 46 AUSTERITY MEASURES WITH POTENTIAL IMPACT ON

BIOSIMILARS MARKET IN ITALY 103

THE 'PAY FOR PERFORMANCE' APPROACH IN ITALY 104

THE UNITED KINGDOM 104

PHARMACEUTICAL P&R PROCESSES IN THE U K 104

HEALTH TECHNOLOGY ASSESSMENT (HTA) IN THE U K 104

Health Technology Assessment … (Continued) 105

TABLE 47 AUTHORITIES OF PHARMACEUTICAL REGULATION

AND P&R PROCESSES IN THE U K 106

MARKET PENETRATION OF BIOSIMILARS IN THE U K 107

FIGURE 1 DEMAND TRENDS OF FILGRASTIM IN THE U K AFTER

THE LAUNCH OF BIOSIMILARS, NOVEMBER 2008-JUNE 2011

(BY VOLUME PERCENT) 108

REST OF THE EU 108

TABLE 48 LAUNCHING DATES OF SELECTED EPO AND

FILGRASTIM BIOSIMILARS IN AUSTRIA, GERMANY, SWEDEN

AND THE NETHERLANDS 109

DENMARK 109

Regulation and Reimbursement 109

Market Penetration of Biosimilars 110

GREECE 110

HUNGARY 111

POLAND 112

SWEDEN 112

THE NETHERLANDS 113

CHAPTER FIVE: BIOSIMILAR MARKETS IN THE U S 114

BIOSIMILAR REGULATION STATUS IN THE U S 114

BIOSIMILAR REGULATION STATUS … (CONTINUED) 115

TABLE 49 KEY LEGISLATIONS SHAPING THE REGULATORY

FRAMEWORK OF THE EVOLVING BIOSIMILARS MARKET IN THE

U S 116

TABLE 49 (CONTINUED) 117

TABLE 50 DIFFERENCES BETWEEN HATCH-WAXMAN PATENT

ENFORCEMENT AND THE BPCIA PATENT FRAMEWORK 117

TABLE 50 (CONTINUED) 118

THE EXISTING REGULATORY PATHWAYS FOR THE

APPROVAL OF DRUGS AND BIOLOGICS IN THE U S 118

TABLE 51 REGULATORY PATHWAYS FOR THE APPROVAL OF

SMALL MOLECULE DRUGS AND BIOLOGIC DRUGS 119

FFDCA and the Approval of Simple Biosimilars 119

Similar Biologic Drugs Marketed in the U S 119

TABLE 52 SIMILAR RECOMBINANT BIOLOGIC PRODUCTS

APPROVED BY THE FDA 120

The Evolving Biosimilar Regulatory Approval Pathway

Based on PPACA and BPCIA 120

TABLE 53 THE EVOLVING BIOSIMILAR PATH TO APPROVAL IN

THE U S 121

TABLE 53 (CONTINUED) 122

TABLE 53 (CONTINUED) 123

"Umbrella Exclusivity" and "Evergreening": The Tussle

over the Exclusivity Provision in BPCIA 124

The Status of the PHS 351 User Fee Proposal by FDA 125

TABLE 54 THE PROPOSED USER FEE PROGRAM FOR

BIOSIMILARS BY THE FDA FOR FISCAL YEARS 2013-2017 126

TABLE 55 PERFORMANCE GOALS PROPOSED FOR THE FDA FOR

APPLICATION REVIEWS 127

TABLE 56 PERFORMANCE GOALS PROPOSED FOR FDA FOR

MEETINGS WITH THE BIOSIMILAR APPLICANT 128

"Totality of the Evidence" Likely to be the Approach by

FDA 128

Interactions between EMA and FDA on Biosimilar

Regulations 129

COMPARISON OF THE EVOLVING FDA REGULATION

WITH THE BIOSIMILAR REGULATIONS ESTABLISHED

BY EMA 129

TABLE 57 COMPARISON OF BIOSIMILAR REGULATORY

APPROACHES OF EMA AND FDA 130

TABLE 57 (CONTINUED) 131

TABLE 57 (CONTINUED) 132

TABLE 57 (CONTINUED) 133

TABLE 57 (CONTINUED) 134

PAYER ACCEPTANCE TRENDS OF BIOSIMILARS IN THE

U S 134

COMPANIES OPTING FOR STANDARD BLAS INSTEAD OF

GOING THE BIOSIMILAR ROUTE 135

THE BIOSIMILAR MARKET IN THE U S 136

TABLE 58 THE BIOSIMILAR MARKET SIZE IN THE U S , THROUGH

2016 ($ MILLIONS) 136

CHAPTER SIX: BIOSIMILAR MARKETS IN THE ASIA-PACIFIC REGION 137

BIOSIMILAR MARKETS IN THE ASIA-PACIFIC REGION 137

THE BIOSIMILAR MARKET SIZE IN ASIA-PACIFIC 138

TABLE 59 THE BIOSIMILAR MARKETS IN APAC, BY PRODUCT

CLASSES THROUGH 2016 ($ MILLIONS) 138

TABLE 60 THE BIOSIMILAR MARKETS IN APAC BY COUNTRY,

THROUGH 2016 (BY VALUE, $ MILLIONS) 138

JAPAN 139

TABLE 61 DRIVERS AND RESTRAINTS OF THE BIOSIMILAR

MARKET IN JAPAN 140

AN OVERVIEW OF BIOSIMILAR REGULATIONS IN JAPAN 140

TABLE 62 IMPORTANT POINTS OF THE BIOSIMILAR

REGULATION IN JAPAN 141

TABLE 62 (CONTINUED) 142

THE BIOSIMILAR MARKET IN JAPAN 142

FIGURE 2 THE JAPANESE BIOSIMILAR MARKET ($ MILLIONS) 143

ELECTRONIC COMPANIES ENTERING THE BIOSIMILAR

SECTOR WITH SIGNIFICANT INVESTMENTS 144

RISING COLLABORATIONS AND ACQUISITIONS

TARGETING THE BIOSIMILAR SECTOR IN JAPAN 144

TABLE 63 RECENT ACQUISITIONS AND PARTNERSHIPS IN JAPAN

IN THE BIOSIMILAR SECTOR 144

TABLE 63 (CONTINUED) 145

SOUTH KOREA 145

BIOVISION 2016 146

REGIONAL BIOCLUSTERS 147

TABLE 64 REGIONAL BIOCLUSTERS IN SOUTH KOREA 147

GOVERNMENT POLICIES TO ATTRACT INVESTMENTS IN

THE BIOTECHNOLOGY SECTOR 147

BIOSIMILAR REGULATORY STATUS IN KOREA 148

TABLE 65 HIGHLIGHTS OF THE BIOSIMILAR REGULATION IN

KOREA 149

TABLE 65 (CONTINUED) 150

BUILDING BIOSIMILAR RESEARCH CAPACITY 150

TABLE 66 RELEVANT AUTHORITIES AND INDUSTRY

ASSOCIATIONS IN KOREA 151

THE BIOSIMILAR SPECIAL PROGRAM ACCELERATING

INVESTMENTS IN THE FIELD 151

TABLE 67 LIST OF RECENT INVESTMENTS IN THE BIOSIMILAR

SECTOR IN KOREA 152

KEY PLAYERS IN THE MARKET 153

TABLE 68 KEY KOREAN PLAYERS IN THE BIOSIMILAR MARKET

WITH COMMERCIALIZED PRODUCTS 153

TABLE 69 KOREAN COMPANIES WITH BIOSIMILAR PRODUCTS IN

ADVANCED STAGES OF DEVELOPMENT 154

TABLE 69 (CONTINUED) 155

TABLE 70 BIOSIMILARS OF MONOCLONAL ANTIBODY

BLOCKBUSTERS UNDER DEVELOPMENT IN KOREA 155

BIOSIMILAR MARKET IN KOREA 156

FIGURE 3 THE KOREAN BIOSIMILAR MARKET BY VALUE 2010-

2016 ($ MILLIONS) 156

FIGURE 3 (CONTINUED) 157

CHINA 157

CHARACTERISTICS AND TRENDS OF THE CHINESE

BIOPHARMACEUTICAL INDUSTRY 157

TABLE 71 CHINESE BIOSIMILAR MARKET: KEY

CHARACTERISTICS 158

TABLE 71 (CONTINUED) 159

Increasing Disease Burden Driving the Market 159

Unmet Medical Needs 160

Lack of Expertise in the Production of Highly Demanding

Products such as Monoclonal Antibodies 160

TABLE 72 MAB PRODUCTS LAUNCHED IN CHINA BY DOMESTIC

COMPANIES 161

Lack of Expertise in…(Continued) 162

TABLE 73 KEY MAB MANUFACTURERS AND THEIR PRODUCTION

CAPACITIES IN CHINA 163

Biopharmaceutical Affordability for Chinese Patients 163

CURRENT REGULATORY LANDSCAPE OF BIOSIMILARS

IN CHINA 163

Current Regulatory Landscape …(Continued) 164

FINANCIAL ENVIRONMENT OF BIOSIMILAR INDUSTRY

IN CHINA 165

TABLE 74 VENTURE CAPITAL FIRMS WITH

HEALTHCARE/BIOTECHNOLOGY COMPANIES IN THEIR

PORTFOLIO IN CHINA 166

TABLE 75 GOVERNMENT PROGRAMS TARGETING PROMOTION

OF INNOVATION IN SCIENCE AND TECHNOLOGY (S&T) IN

CHINA 167

TABLE 75 (CONTINUED) 168

TABLE 75 (CONTINUED) 169

ADOPTION OF HYBRID BUSINESS MODELS 170

Biotech Parks in China 170

Key Players in the Market 170

TABLE 76 BIOSIMILAR COMPANIES AND THEIR PRODUCTS IN

CHINA 170

TABLE 76 (CONTINUED) 171

THE BIOSIMILAR MARKET IN CHINA 171

FIGURE 4 THE CHINESE BIOSIMILAR MARKET BY VALUE, 2010-

2016 ($ MILLIONS) 172

FIGURE 4 (CONTINUED) 173

INDIA 173

TABLE 77 DRIVERS OF INDIAN BIOSIMILAR MARKET 174

RISING INVESTMENTS IN INDIAN BIOSIMILAR SECTOR 175

TABLE 78 BIOSIMILAR-RELATED INVESTMENTS AND BUSINESS

DEALS BY INDIAN COMPANIES 175

TABLE 78 (CONTINUED) 176

GOVERNMENT INITIATIVES 176

Government Initiatives (Continued) 177

TABLE 79 THE BIOTECH PARKS IN INDIA 178

TABLE 79 (CONTINUED) 179

TABLE 79 (CONTINUED) 180

THE REGULATORY LANDSCAPE OF BIOSIMILAR

INDUSTRY IN INDIA 180

TABLE 80 IMPORTANT REGULATIONS INFLUENCING

BIOSIMILAR INDUSTRY GROWTH IN INDIA 181

TABLE 80 (CONTINUED) 182

TABLE 81 AUTHORITIES IN INDIA RELATED TO BIOSIMILAR

INDUSTRY REGULATIONS AND THEIR RESPONSIBILITIES 182

TABLE 81 (CONTINUED) 183

REGISTRATION PROCESS OF A BIOSIMILAR DRUG IN

INDIA 183

THE FINANCIAL ENVIRONMENT OF BIOSIMILAR

INDUSTRY IN INDIA 184

THE TECHNOLOGICAL CAPABILITIES OF INDIA IN THE

BIOSIMILAR FIELD 185

TABLE 82 TECHNOLOGICAL CHALLENGES OF BIOSIMILAR

COMPANIES IN INDIA 186

THE BIOSIMILAR MARKET IN INDIA 187

TABLE 83 KEY PLAYERS AND THEIR PRODUCTS IN THE INDIAN

BIOSIMILAR MARKET 187

TABLE 83 (CONTINUED) 188

FIGURE 5 THE INDIAN BIOSIMILAR MARKET BY VALUE, 2010-2016

($ MILLIONS) 188

REST OF APAC 189

AUSTRALIA 189

SINGAPORE 190

TAIWAN 191

TABLE 84 BIOTECHNOLOGY FOCUSED SCIENCE PARKS IN

TAIWAN 192

Taiwan (Continued) 193

THE BIOSIMILAR MARKET IN REST OF APAC 194

FIGURE 6 THE BIOSIMILAR MARKET FOR THE REST OF APAC,

THROUGH 2016 ($ MILLIONS) 194

CHAPTER SEVEN REST OF THE WORLD (ROW) MARKETS 195

REST OF THE WORLD (ROW) MARKETS 195

TABLE 85 THE MARKET SIZE OF BIOSIMILARS IN ROW BY VALUE,

THROUGH 2016 ($ MILLIONS) 196

CANADA 196

CUBA 197

Cuba (Continued) 198

BRAZIL 199

TABLE 86 AGENCIES/ OFFICES INVOLVED IN PHARMACEUTICAL

REGULATION IN BRAZIL 200

TABLE 86 (CONTINUED) 201

TABLE 87 KEY REGULATIONS SHAPING THE PHARMACEUTICAL

INDUSTRY IN BRAZIL 202

MEXICO 203

ISRAEL 204

RUSSIA 205

Russia (Continued) 206

CHAPTER EIGHT: TECHNOLOGY TRENDS 207

TRENDS IN BIOSIMILAR MANUFACTURING PROCESSES 207

NEW TRENDS IN CELL LINE DEVELOPMENT 207

TABLE 88 EMERGING TECHNOLOGY PLATFORMS FOR

BIOSIMILAR CELL LINE DEVELOPMENT 208

TABLE 88 (CONTINUED) 209

ALTERNATE HOST SYSTEMS 209

SCAFFOLD/MATRIX ATTACHMENT REGIONS (S/MARS) 210

UBIQUITOUS CHROMATIN OPENING ELEMENTS (UCOE) 210

ZINC FINGER MEDIATED HOST CELL ENGINEERING 210

TRANSIENT GENE EXPRESSION (TGE) 211

REGULATORY RNA ENGINEERING 211

SINGLE-USE SYSTEMS AND WAREHOUSE

MANUFACTURING 211

EMERGING TRENDS IN ANALYTICAL TECHNOLOGIES 212

TABLE 89 CHALLENGES OF ANALYTICAL CHARACTERIZATION

OF BIOSIMILAR PRODUCTS 213

TABLE 90 ANALYTICAL METHODS RECOGNIZED BY REGULATORY

BODIES FOR COMPARABILITY EXERCISE AND RISK

MITIGATION 214

TABLE 90 (CONTINUED) 215

POLYACRYLAMIDE GEL ELECTROPHORESIS (PAGE) AND

WESTERN BLOTTING 215

ISOELECTRIC FOCUSING (IEF)/PROTEIN BLOTTING 215

CAPILLARY ZONE ELECTROPHORESIS (CZE) 216

HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

(HPLC) 216

SPECTROSCOPIC TECHNIQUES 216

MASS SPECTROMETRY (MS) 217

IN VITRO ASSAYS 217

EPITOPE MAPPING 218

DIFFERENTIAL SCANNING CALORIMETRY (DSC) 218

CHAPTER NINE: PATENT ANALYSIS 219

PATENT ANALYSIS 219

TABLE 91 U S PATENTS OF MOMENTA PHARMACEUTICALS ON

ANALYTICAL METHODS FOR LMWH CHARACTERIZATION 220

TABLE 92 INTERNATIONAL PATENTS ON BIOSIMILAR PRODUCTS

BY SELECTED INDUSTRY PLAYERS 221

TABLE 92 (CONTINUED) 222

CHAPTER NINE: COMPANY PROFILES 223

3SBIO INC 223

TABLE 93 BIOSIMILAR PRODUCTS MARKETED BY 3SBIO 224

AMOYTOP BIOTECH CO , LTD 225

ANHUI ANKE BIOTECHNOLOGY(GROUP) CO , LTD 225

APOTEX INC 226

AVESTHAGEN LIMITED 226

BEIJING FOUR RINGS BIOPHARMACEUTICAL CO , LTD 227

BEIJING SL PHARMACEUTICAL CO , LTD 228

BHARAT SERUMS AND VACCINES LTD 228

BIOCON LTD 229

TABLE 94 SOME OF THE RECENT PARTNERSHIP, ACQUISITION,

AND DIVESTMENT DEALS BY BIOCON 230

BIOXPRESS THERAPEUTICS SA 231

TABLE 95 PIPELINE BIOSIMILAR MABS OF BIOXPRESS

THERAPEUTICS SA 231

TABLE 95 (CONTINUED) 232

BIOTON S A 232

TABLE 96 BIOTON GROUP COMPANIES WORLDWIDE 233

BLAU FARMACÊUTICA S/A 234

BOEHRINGER INGELHEIM 234

CELLTRION GROUP 235

TABLE 97 MARKETING AND CRO PARTNERS OF CELLTRION IN

VARIOUS COUNTRIES 235

TABLE 97 (CONTINUED) 236

TABLE 98 BIOSIMILAR PIPELINE OF CELLTRION 237

CHINA NATIONAL BIOTECH CORPORATION (CNBC) 238

CIPLA LIMITED 238

CINNAGEN 239

CJSC BIOCAD 239

TABLE 99 BIOPHARMACEUTICALS DEVELOPED AND MARKETED

BY BIOCAD 240

CURAXYS 240

DONG-A PHARMACEUTICAL CO , LTD 241

TABLE 100 BIOSIMILAR PRODUCTS OF DONG-A

PHARMACEUTICALS 242

DR REDDY'S LABORATORIES LTD 242

DR REDDY'S LABORATORIES LTD (CONTINUED) 243

TABLE 101 BIOSIMILAR PRODUCTS MARKETED BY DR REDDY'S

LABORATORIES 244

EMCURE PHARMACEUTICALS LTD 244

FERON LTD 245

FINOX BIOTECH 245

FUJIFILM CORPORATION 246

GEDEON RICHTER PLC 247

GENESCIENCE PHARMACEUTICALS CO , LTD (GENSCI) 247

GENEXINE CO LTD 248

G H GENHELIX S A 248

GREEN CROSS LIFE SCIENCE CORPORATION 249

HANGZHOU JIUYUAN GENE ENGINEERING CO , LTD 250

HANALL PHARMACEUTICAL CO , LTD 250

HANWHA CHEMICAL CORPORATION 251

HOSPIRA, INC 251

TABLE 102 BIOSIMILAR-RELATED INVESTMENTS BY HOSPIRA 252

TABLE 102 (CONTINUED) 253

TABLE 103 BIOSIMILAR PIPELINE OF HOSPIRA 253

TABLE 103 (CONTINUED) 254

INTAS BIOPHARMACEUTICALS LTD 254

TABLE 104 IBPL'S BIOSIMILAR PRODUCTS IN THE MARKET 255

TABLE 105 MARKETING PARTNERSHIPS ESTABLISHED BY INTAS

IN VARIOUS MARKETS 256

JCR PHARMACEUTICALS CO , LTD 256

TABLE 106 RECOMBINANT BIOSIMILAR PIPELINE OF JCR

PHARMACEUTICALS 257

KISSEI PHARMACEUTICALS CO , LTD 257

LG LIFE SCIENCES 258

TABLE 107 BIOLOGIC DRUGS DEVELOPED AND MARKETED BY

LGLS 258

MEDICE ARZNEIMITTEL PUTTER GMBH AND CO KG 259

MERCK BIOVENTURES 259

MJ BIOPHARMA PVT LTD 260

MOMENTA PHARMACEUTICALS 261

MYCENAX BIOTECH INC 261

NANOGEN BIOPHARMA 262

NCPC GENETECH BIOTECHNOLOGY CO , LTD 262

NEUCLONE PTY LIMITED 263

NIPPON KAYAKU CO , LTD 264

TABLE 108 BIOSIMILAR PRODUCTS UNDER DEVELOPMENT BY

NIPPON KAYAKU, JAPAN 264

PHARMAPARK LLC 264

PLANTFORM CORPORATION 265

PROBIOMED S A DE C V 265

RANBAXY LABORATORIES LTD 266

RANBAXY LABORATORIES LTD (CONTINUED) 267

RELIANCE LIFE SCIENCES PVT LTD 268

TABLE 109 BIOSIMILARS DEVELOPED AND MARKETED BY

RELIANCE LIFE SCIENCES 269

SAMSUNG BIOLOGICS 269

TABLE 110 PARTNERING COMPANIES INVOLVED IN THE

ESTABLISHMENT OF SAMSUNG BIOLOGICS 270

SANDOZ INTERNATIONAL GMBH 270

SCINOPHARM TAIWAN, LTD 271

SHANDONG GENELEUK BIOPHARMACEUTICAL CO , LTD 272

SHANDONG KEXING BIOPRODUCTS CO , LTD 273

SHANGHAI CELGEN BIOPHARMACEUTICAL CO, LTD 273

SHANGHAI CP GUOJIAN PHARMACEUTICAL CO , LTD 274

SHANGHAI HUAXIN HIGH BIOTECHNOLOGY INC 275

SHANGHAI UNITED CELL BIOTECHNOLOGY CO , LTD 275

SHANGHAI WANXING BIO-PHARMACEUTICAL CO LTD 276

SHANTHA BIOTECHNICS 276

SHENZHEN HEPALINK PHARMACEUTICAL CO , LTD 277

SHENZHEN NEPTUNUS INTERLONG BIO-TECHNIQUE CO , LTD 278

SHENZHEN TECHDOW PHARMACEUTICAL CO , LTD 278

SHENZHEN XINPENG BIO-TECH CO , LTD 279

SICOR BIOTECH UAB 279

SOTEX PHARMACEUTICAL FIRM ZAO 280

STADA-ARZNEIMITTEL AG (STADA) 280

TEVA PHARMACEUTICAL INDUSTRIES LTD 281

TABLE 111 MARKETED AND PIPELINE BIOSIMILAR PRODUCTS

OF TEVA PHARMACEUTICALS 282

TABLE 112 PARTNERING DEALS/ACQUISITIONS BY TEVA

TARGETING THE DEVELOPMENT OF BIOPHARMACEUTICAL

PIPELINE 282

TABLE 112 (CONTINUED) 283

TIANJIN HUALIDA BIOTECHNOLOGY CO , LTD 283

USV LIMITED 284

WOCKHARDT LTD 284

TABLE 113 BIOSIMILAR PRODUCTS MARKETED BY WOCKHARDT 285

WATSON PHARMACEUTICALS, INC 286

ZHONGSHAN HYGENE BIOPHARM CO , LTD 286

APPENDIX 287

TABLE 114 GLOSSARY 287

TABLE 114 (CONTINUED) 288

TABLE 114 (CONTINUED) 289

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