Biosimilars: Global Markets

  • May 2012
  • -
  • BCC Research
  • -
  • 289 pages

REPORT SCOPE

INTRODUCTION

Biosimilars are comparable versions of original biopharmaceuticals. Since biologics are highly complex molecules, it is not possible to make identical copies of them. Hence, these products are not technically biogenerics. The differences of the biosimilar products from the reference biologic drug can be attributed to various manufacturing details including differences in expression systems, cell cultures, and many other bioprocessing conditions in the process.

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

Rising healthcare costs are driving the need for affordable yet effective biologic drugs for the treatment of various therapeutic conditions. Even though regulatory framework for the approval of biosimilars was in place in Europe for over five years, the market penetration has been slow. The safety concerns and the relatively lower cost advantages are the main restraints for this sector in regulated markets. In semi- and unregulated markets, the affordability is poor even for biologic drugs including biosimilars. However, progress in the scientific understanding of biologic drugs and improvements in the bioprocessing and analytical testing methodologies indicate high potential for significant cost reduction in the development of biosimilars. This is creating a situation that is challenging the market exclusivity being enjoyed by biologic innovator brands even after losing their patent protection. Since more blockbuster biologic drugs are losing patent protection, the interest in the sector is increasing worldwide. Aspirant companies include even multinational pharmaceutical and biotechnology companies as indicated by the recent investment trends in the sector. Even multinationals in the electronics industry are making strategic entry with huge investments. In this context, it is interesting to analyze the market trends and future growth potentials.

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

This study provides valuable perspective on the regulatory framework worldwide that is playing a key role in shaping the biosimilar market. The scientific improvements and their influence in shaping the market are also analyzed in depth. Valuable insights on the investment trends and business models adopted by different key players in various parts of the world are provided. Various product classes that are getting attention from the biosimilar players and their therapeutic areas are analyzed and their future market trends are forecast.

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

Both primary and secondary research methodologies were used in preparing this study. The base year is 2011. The market size reflects the global revenues of drugs within the product classes recognized as biosimilars by EMA. Advanced pipeline products with high chances of entering the market during the forecast period are considered for market forecasts. The sales represent total revenues, which include the sales of these products in the respective markets.

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

Syamala Ariyanchira is actively involved in technology assessment, strategic planning, competitor analysis, due diligence, and market analysis. She combines her technical background with current business sector issues with ease. Her clients include investment firms, government agencies, and chemical and pharmaceutical companies. She holds a Ph.D. from Indian Institute of Science, Bangalore, India, and has over sixteen years of experience in the industry.

Table Of Contents

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 (PandR) 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
PandR SCENARIO OF BIOSIMILARS ACROSS EU5 82
TABLE 38 PHARMACEUTICAL PandR 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
PandR 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 PandR 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 PandR 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 (SandT) 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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