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Biosimilars: Global Markets

Abstract

REPORT HIGHLIGHTS

The global market for biosimilars reached $1.7 billion in 2010 and $2.5 billion in 2011. The market is expected to reach $3.6 billion by 2016, a compound annual growth rate (CAGR) of 7.7%.

The market in the APAC region for biosimilars reached $605 million in 2010 and $683 million in 2011. The market is expected to reach $1.1 billion by 2016, a CAGR of 10.3%.

The market in the United States for biosimilars reached $507 million in 2010 and $1.1 billion in 2011. The market is expected to reach $1.3 billion by 2016, a CAGR of 4.1%.

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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

Chapter- 1: INTRODUCTION - Complimentary

  • STUDY GOAL AND OBJECTIVES
  • INTENDED AUDIENCE OF THE STUDY
  • MARKET DEFINITION, SCOPE AND FORMAT
  • INFORMATION SOURCES AND METHODOLOGY
  • AUTHOR'S CREDENTIALS
  • RELATED REPORTS FROM BCC RESEARCH
  • BCC ONLINE SERVICES
  • DISCLAIMER

Chapter- 2: SUMMARY

  • Table Summary : GLOBAL DEMAND FOR BIOSIMILARS BY VALUE, THROUGH 2016
  • Figure Summary : GLOBAL BIOSIMILAR DEMAND BY VALUE AND PRODUCT TYPE, 2011

Chapter- 3: MARKET OVERVIEW

  • THE TERMINOLOGY
  • THE BIOSIMILAR OPPORTUNITY
  • WORLDWIDE MARKETS FOR BIOSIMILARS - CURRENT STATUS
  • THE EVOLVING BIOSIMILAR REGULATORY LANDSCAPE
  • DATA EXCLUSIVITY
  • AN OVERVIEW OF THE CURRENT REGULATORY PRACTICES IN U.S., EUROPE, AND SEMI-REGULATED MARKETS
  • PARTNERSHIPS, COLLABORATIONS, LICENSING AND ACQUISITIONS DRIVING BIOSIMILAR DEVELOPMENT
  • BIG PHARMA KEEN TO TAP THE BIOSIMILAR OPPORTUNITY
  • Table 1 : SIMILAR BIOLOGICAL PRODUCTS: TERMINOLOGIES AND THEIR DEFINITIONS AS USED BY VARIOUS REGULATORY AGENCIES

Chapter- 4: BIOSIMILAR MARKETS IN EUROPE

  • LEGISLATION AND POLICIES IN THE EU AND MEMBER STATES
  • REFERENCE PRODUCTS AND THEIR MARKET EXCLUSIVITY PERIODS IN THE EU
  • THE MARKET AUTHORIZATION PROCESS OF BIOSIMILARS IN THE EU
  • AVAILABILITY OF BIOSIMILARS IN MEMBER STATES
  • THE BIOSIMILAR MARKET IN EU
  • HEALTH CONCERNS REGARDING INTERCHANGEABILITY - A KEY CHALLENGE
  • COMPLEXITY ASSOCIATED WITH BIOSIMILAR PRODUCTION IS LEADING TO SUPPLY SHORTAGES IN EUROPE
  • ABBREVIATION OF REGULATORY ASSESSMENTS OF BIOSIMILARS
  • THE PRICING AND REIMBURSEMENT (P&R) POLICIES ACROSS THE MEMBER STATES
  • GERMANY
  • FRANCE
  • SPAIN
  • ITALY
  • THE UNITED KINGDOM
  • REST OF THE EU
  • Table 25 : MAIN BIOSIMILAR REGULATORY TEXTS IN EU
  • Table 26 : BIOSIMILAR GUIDELINES PUBLISHED IN THE EU

Chapter- 5: BIOSIMILAR MARKETS IN THE U.S.

  • BIOSIMILAR REGULATION STATUS IN THE U.S.
  • Table 49 : KEY LEGISLATIONS SHAPING THE REGULATORY FRAMEWORK OF THE EVOLVING BIOSIMILARS MARKET IN THE U.S.
  • Table 50 : DIFFERENCES BETWEEN HATCH-WAXMAN PATENT ENFORCEMENT AND THE BPCIA PATENT FRAMEWORK

Chapter- 6: BIOSIMILAR MARKETS IN THE ASIA-PACIFIC REGION

  • THE BIOSIMILAR MARKET SIZE IN ASIA-PACIFIC
  • JAPAN
  • SOUTH KOREA
  • CHINA
  • INDIA
  • REST OF APAC
  • Table 59 : THE BIOSIMILAR MARKETS IN APAC, BY PRODUCT CLASSES THROUGH 2016
  • Table 60 : THE BIOSIMILAR MARKETS IN APAC BY COUNTRY, THROUGH 2016

Chapter- 7: REST OF THE WORLD (ROW) MARKETS

  • CANADA
  • CUBA
  • BRAZIL
  • MEXICO
  • ISRAEL
  • RUSSIA

Chapter- 8: TECHNOLOGY TRENDS

  • TRENDS IN BIOSIMILAR MANUFACTURING PROCESSES

Chapter- 9: PATENT ANALYSIS

  • Table 91 : U.S. PATENTS OF MOMENTA PHARMACEUTICALS ON ANALYTICAL METHODS FOR LMWH CHARACTERIZATION
  • Table 92 : INTERNATIONAL PATENTS ON BIOSIMILAR PRODUCTS BY SELECTED INDUSTRY PLAYERS

Chapter- 10: COMPANY PROFILES

  • 3SBIO INC.
  • AMOYTOP BIOTECH CO., LTD
  • ANHUI ANKE BIOTECHNOLOGY(GROUP) CO., LTD.
  • APOTEX INC.
  • AVESTHAGEN LIMITED
  • BEIJING FOUR RINGS BIOPHARMACEUTICAL CO., LTD.
  • BEIJING SL PHARMACEUTICAL CO., LTD.
  • BHARAT SERUMS AND VACCINES LTD
  • BIOCON LTD.
  • BIOXPRESS THERAPEUTICS SA
  • BIOTON S. A.
  • BLAU FARMACEUTICA S/A
  • BOEHRINGER INGELHEIM
  • CELLTRION GROUP
  • CHINA NATIONAL BIOTECH CORPORATION (CNBC)
  • CIPLA LIMITED
  • CINNAGEN
  • CJSC BIOCAD
  • CURAXYS
  • DONG-A PHARMACEUTICAL CO., LTD
  • DR. REDDY'S LABORATORIES LTD.
  • EMCURE PHARMACEUTICALS LTD.
  • FERON LTD.
  • FINOX BIOTECH
  • FUJIFILM CORPORATION
  • GEDEON RICHTER PLC.
  • GENESCIENCE PHARMACEUTICALS CO., LTD. (GENSCI)
  • GENEXINE CO. LTD
  • G. H. GENHELIX S.A.
  • GREEN CROSS LIFE SCIENCE CORPORATION
  • HANGZHOU JIUYUAN GENE ENGINEERING CO., LTD.
  • HANALL PHARMACEUTICAL CO., LTD.
  • HANWHA CHEMICAL CORPORATION
  • HOSPIRA, INC.
  • INTAS BIOPHARMACEUTICALS LTD.
  • JCR PHARMACEUTICALS CO., LTD.
  • KISSEI PHARMACEUTICALS CO., LTD.
  • LG LIFE SCIENCES
  • MEDICE ARZNEIMITTEL PUTTER GMBH AND CO. KG
  • MERCK BIOVENTURES
  • MJ BIOPHARMA PVT. LTD.
  • MOMENTA PHARMACEUTICALS
  • MYCENAX BIOTECH INC.
  • NANOGEN BIOPHARMA
  • NCPC GENETECH BIOTECHNOLOGY CO., LTD.
  • NEUCLONE PTY. LIMITED
  • NIPPON KAYAKU CO., LTD.
  • PHARMAPARK LLC
  • PLANTFORM CORPORATION
  • PROBIOMED S.A. DE C.V.
  • RANBAXY LABORATORIES LTD.
  • RELIANCE LIFE SCIENCES PVT LTD
  • SAMSUNG BIOLOGICS
  • SANDOZ INTERNATIONAL GMBH
  • SCINOPHARM TAIWAN, LTD.
  • SHANDONG GENELEUK BIOPHARMACEUTICAL CO., LTD.
  • SHANDONG KEXING BIOPRODUCTS CO., LTD.
  • SHANGHAI CELGEN BIOPHARMACEUTICAL CO, LTD.
  • SHANGHAI CP GUOJIAN PHARMACEUTICAL CO., LTD.
  • SHANGHAI HUAXIN HIGH BIOTECHNOLOGY INC.
  • SHANGHAI UNITED CELL BIOTECHNOLOGY CO., LTD.
  • SHANGHAI WANXING BIO-PHARMACEUTICAL CO. LTD
  • SHANTHA BIOTECHNICS
  • SHENZHEN HEPALINK PHARMACEUTICAL CO., LTD.
  • SHENZHEN NEPTUNUS INTERLONG BIO-TECHNIQUE CO., LTD.
  • SHENZHEN TECHDOW PHARMACEUTICAL CO., LTD.
  • SHENZHEN XINPENG BIO-TECH CO., LTD
  • SICOR BIOTECH UAB
  • SOTEX PHARMACEUTICAL FIRM ZAO
  • STADA-ARZNEIMITTEL AG (STADA)
  • TEVA PHARMACEUTICAL INDUSTRIES LTD.
  • TIANJIN HUALIDA BIOTECHNOLOGY CO., LTD.
  • USV LIMITED
  • WOCKHARDT LTD.
  • WATSON PHARMACEUTICALS, INC.
  • ZHONGSHAN HYGENE BIOPHARM CO., LTD.
  • Table 93 : BIOSIMILAR PRODUCTS MARKETED BY 3SBIO

Chapter- 11: APPENDIX

  • Table 114 : GLOSSARY

List of Tables

  • Summary Table : GLOBAL DEMAND FOR BIOSIMILARS BY VALUE, THROUGH 2016
  • Table 1 : SIMILAR BIOLOGICAL PRODUCTS: TERMINOLOGIES AND THEIR DEFINITIONS AS USED BY VARIOUS REGULATORY AGENCIES
  • Table 2 : BIOSIMILARS VERSUS SMALL MOLECULE GENERICS
  • Table 3 : GLOBAL REVENUES OF LEADING BIOPHARMACEUTICALS
  • Table 4 : BIOLOGIC DRUGS LOSING PATENT PROTECTION BETWEEN 2012 AND 2017
  • Table 5 : POPULAR REFERENCE PRODUCTS TARGETED BY KEY PLAYERS
  • Table 6 : ANNUAL COSTS FOR THE TREATMENT USING SOME OF THE BIOLOGIC DRUGS
  • Table 7 : COST COMPARISON FOR RENAL DISEASE-ASSOCIATED ANEMIA TREATMENT IN EUROPE
  • Table 8 : BIOSIMILARS APPROVED BY EMA, 2011
  • Table 9 : BIOSIMILARS APPROVED IN OTHER REGULATED MARKETS - AUSTRALIA, CANADA, JAPAN, AND THE U.S.
  • Table 10 : TOP PLAYERS IN THE GLOBAL BIOSIMILAR MARKET
  • Table 11 : THE GLOBAL AND REGIONAL BIOSIMILAR MARKETS BY VALUE THROUGH 2016
  • Table 12 : THE GLOBAL MARKETS FOR VARIOUS PRODUCT CLASSES OF BIOSIMILARS BY VALUE, THROUGH 2016
  • Table 13 : SCIENTIFIC AND REGULATORY CONCERNS RELATED TO BIOSIMILAR AUTHORIZATION
  • Table 14 : COMMON BIOLOGICS AND THEIR IMMUNOGENICITY POTENTIALS
  • Table 15 : DATA EXCLUSIVITY PERIODS OF REFERENCE FOR BIOLOGIC DRUGS IN EU, U.S. AND JAPAN
  • Table 16 : BIOSIMILAR REGULATION: CURRENT STATUS IN EU AND U.S.
  • Table 17 : BIOSIMILAR GUIDELINES FEATURES ADOPTED BY JAPAN, CANADA AND WHO
  • Table 18 : BIOSIMILAR TARGETED BUSINESS DEALS SIGNED IN 2011
  • Table 19 : RECENT BIOSIMILAR DEALS MADE BY MULTINATIONAL PHARMACEUTICAL COMPANIES
  • Table 20 : KEY CHALLENGES OF THE GLOBAL BIOSIMILAR MARKET
  • Table 21 : KEY CONCERNS OF CHMP REGARDING THE INSULIN BIOSIMILAR APPLICATIONS BY MARVEL LIFE SCIENCES
  • Table 22 : FACTORS INFLUENCING THE PRICING STRATEGIES FOR BIOSIMILARS
  • Table 23 : BIOSIMILAR PRODUCTS IN ADVANCED STAGES OF DEVELOPMENT WORLDWIDE
  • Table 24 : DETAILS OF BIOSIMILAR APPROVALS IN THE EU
  • Table 25 : MAIN BIOSIMILAR REGULATORY TEXTS IN EU
  • Table 26 : BIOSIMILAR GUIDELINES PUBLISHED IN THE EU
  • Table 27 : NUMBER OF YEARS OF EFFECTIVE MARKET EXCLUSIVITY ENJOYED BY SOME OF THE INNOVATOR BRANDS ACROSS EU5
  • Table 28 : SUMMARY OF THE MARKET AUTHORIZATION PROCESS OF BIOSIMILARS IN THE EU
  • Table 29 : LAUNCHING DATES OF BIOSIMILAR BRANDS ACROSS VARIOUS EU MEMBER STATES
  • Table 30 : THE BIOSIMILAR MARKET IN THE EU BY VALUE, THROUGH 2016
  • Table 31 : THE RISING MARKET SHARE OF BIOSIMILARS IN THE EU MARKET, 2007-2011
  • Table 32 : THE MARKET PENETRATION OF SOMATROPIN, ERYTHROPOIETIN AND FILGRASTIM BIOSIMILARS ACROSS EU5, 2011
  • Table 33 : BIOSIMILAR ACCEPTANCE IN SELECTED NON-EU5 MEMBER STATES
  • Table 34 : POLICIES REGARDING AUTOMATIC SUBSTITUTION OF BIOSIMILARS ACROSS THE EU
  • Table 35 : POTENTIAL INFLUENCE OF THE PRICE APPROVAL DELAYS ON LAUNCHING PRIORITIES BY BIOSIMILAR COMPANIES IN SELECTED EU MEMBER STATES
  • Table 36 : REFERENCE PRICING SYSTEMS IMPLEMENTED IN EU MEMBER STATES
  • Table 37 : COMPARISON OF THE POLICIES INFLUENCING THE P&R SCENARIO OF BIOSIMILARS ACROSS EU5
  • Table 38 : PHARMACEUTICAL P&R POLICIES AND PROCESSES IN SELECTED NON-EU5 MEMBER STATES
  • Table 39 : THE IMPACT OF EPO BIOSIMILAR ENTRY IN GERMANY
  • Table 40 : DRIVERS OF THE BIOSIMILAR MARKET IN GERMANY
  • Table 41 : REGIONAL PRESCRIPTION QUOTAS FOR EPO BIOSIMILARS IN GERMANY
  • Table 42 : REGULATORY AUTHORITIES/ORGANIZATIONS INVOLVED IN MARKET AUTHORIZATION OF MEDICINES IN FRANCE
  • Table 43 : ORGANIZATIONS AND COMMITTEES INVOLVED IN THE PHARMACEUTICAL REGULATION PROCESSES IN ITALY
  • Table 44 : NEGOTIATED PRICE REDUCTIONS FOR BIOSIMILARS COMMERCIALIZED IN ITALY
  • Table 45 : BIOSIMILARS AVAILABLE IN ITALY
  • Table 46 : AUSTERITY MEASURES WITH POTENTIAL IMPACT ON BIOSIMILARS MARKET IN ITALY
  • Table 47 : AUTHORITIES OF PHARMACEUTICAL REGULATION AND P&R PROCESSES IN THE U.K.
  • Table 48 : LAUNCHING DATES OF SELECTED EPO AND FILGRASTIM BIOSIMILARS IN AUSTRIA, GERMANY, SWEDEN AND THE NETHERLANDS
  • Table 49 : KEY LEGISLATIONS SHAPING THE REGULATORY FRAMEWORK OF THE EVOLVING BIOSIMILARS MARKET IN THE U.S.
  • Table 50 : DIFFERENCES BETWEEN HATCH-WAXMAN PATENT ENFORCEMENT AND THE BPCIA PATENT FRAMEWORK
  • Table 51 : REGULATORY PATHWAYS FOR THE APPROVAL OF SMALL MOLECULE DRUGS AND BIOLOGIC DRUGS
  • Table 52 : SIMILAR RECOMBINANT BIOLOGIC PRODUCTS APPROVED BY THE FDA
  • Table 53 : THE EVOLVING BIOSIMILAR PATH TO APPROVAL IN THE U.S.
  • Table 54 : THE PROPOSED USER FEE PROGRAM FOR BIOSIMILARS BY THE FDA FOR FISCAL YEARS 2013-2017
  • Table 55 : PERFORMANCE GOALS PROPOSED FOR THE FDA FOR APPLICATION REVIEWS
  • Table 56 : PERFORMANCE GOALS PROPOSED FOR FDA FOR MEETINGS WITH THE BIOSIMILAR APPLICANT
  • Table 57 : COMPARISON OF BIOSIMILAR REGULATORY APPROACHES OF EMA AND FDA
  • Table 58 : THE BIOSIMILAR MARKET SIZE IN THE U.S., THROUGH 2016
  • Table 59 : THE BIOSIMILAR MARKETS IN APAC, BY PRODUCT CLASSES THROUGH 2016
  • Table 60 : THE BIOSIMILAR MARKETS IN APAC BY COUNTRY, THROUGH 2016
  • Table 61 : DRIVERS AND RESTRAINTS OF THE BIOSIMILAR MARKET IN JAPAN
  • Table 62 : IMPORTANT POINTS OF THE BIOSIMILAR REGULATION IN JAPAN
  • Table 63 : RECENT ACQUISITIONS AND PARTNERSHIPS IN JAPAN IN THE BIOSIMILAR SECTOR
  • Table 64 : REGIONAL BIOCLUSTERS IN SOUTH KOREA
  • Table 65 : HIGHLIGHTS OF THE BIOSIMILAR REGULATION IN KOREA
  • Table 66 : RELEVANT AUTHORITIES AND INDUSTRY ASSOCIATIONS IN KOREA
  • Table 67 : LIST OF RECENT INVESTMENTS IN THE BIOSIMILAR SECTOR IN KOREA
  • Table 68 : KEY KOREAN PLAYERS IN THE BIOSIMILAR MARKET WITH COMMERCIALIZED PRODUCTS
  • Table 69 : KOREAN COMPANIES WITH BIOSIMILAR PRODUCTS IN ADVANCED STAGES OF DEVELOPMENT
  • Table 70 : BIOSIMILARS OF MONOCLONAL ANTIBODY BLOCKBUSTERS UNDER DEVELOPMENT IN KOREA
  • Table 71 : CHINESE BIOSIMILAR MARKET: KEY CHARACTERISTICS
  • Table 72 : MAB PRODUCTS LAUNCHED IN CHINA BY DOMESTIC COMPANIES
  • Table 73 : KEY MAB MANUFACTURERS AND THEIR PRODUCTION CAPACITIES IN CHINA
  • Table 74 : VENTURE CAPITAL FIRMS WITH HEALTHCARE/BIOTECHNOLOGY COMPANIES IN THEIR PORTFOLIO IN CHINA
  • Table 75 : GOVERNMENT PROGRAMS TARGETING PROMOTION OF INNOVATION IN SCIENCE AND TECHNOLOGY (S&T) IN CHINA
  • Table 76 : BIOSIMILAR COMPANIES AND THEIR PRODUCTS IN CHINA
  • Table 77 : DRIVERS OF INDIAN BIOSIMILAR MARKET
  • Table 78 : BIOSIMILAR-RELATED INVESTMENTS AND BUSINESS DEALS BY INDIAN COMPANIES
  • Table 79 : THE BIOTECH PARKS IN INDIA
  • Table 80 : IMPORTANT REGULATIONS INFLUENCING BIOSIMILAR INDUSTRY GROWTH IN INDIA
  • Table 81 : AUTHORITIES IN INDIA RELATED TO BIOSIMILAR INDUSTRY REGULATIONS AND THEIR RESPONSIBILITIES
  • Table 82 : TECHNOLOGICAL CHALLENGES OF BIOSIMILAR COMPANIES IN INDIA
  • Table 83 : KEY PLAYERS AND THEIR PRODUCTS IN THE INDIAN BIOSIMILAR MARKET
  • Table 84 : BIOTECHNOLOGY FOCUSED SCIENCE PARKS IN TAIWAN
  • Table 85 : THE MARKET SIZE OF BIOSIMILARS IN ROW BY VALUE, THROUGH 2016
  • Table 86 : AGENCIES/ OFFICES INVOLVED IN PHARMACEUTICAL REGULATION IN BRAZIL
  • Table 87 : KEY REGULATIONS SHAPING THE PHARMACEUTICAL INDUSTRY IN BRAZIL
  • Table 88 : EMERGING TECHNOLOGY PLATFORMS FOR BIOSIMILAR CELL LINE DEVELOPMENT
  • Table 89 : CHALLENGES OF ANALYTICAL CHARACTERIZATION OF BIOSIMILAR PRODUCTS
  • Table 90 : ANALYTICAL METHODS RECOGNIZED BY REGULATORY BODIES FOR COMPARABILITY EXERCISE AND RISK MITIGATION
  • Table 91 : U.S. PATENTS OF MOMENTA PHARMACEUTICALS ON ANALYTICAL METHODS FOR LMWH CHARACTERIZATION
  • Table 92 : INTERNATIONAL PATENTS ON BIOSIMILAR PRODUCTS BY SELECTED INDUSTRY PLAYERS
  • Table 93 : BIOSIMILAR PRODUCTS MARKETED BY 3SBIO
  • Table 94 : SOME OF THE RECENT PARTNERSHIP, ACQUISITION, AND DIVESTMENT DEALS BY BIOCON
  • Table 95 : PIPELINE BIOSIMILAR MABS OF BIOXPRESS THERAPEUTICS SA
  • Table 96 : BIOTON GROUP COMPANIES WORLDWIDE
  • Table 97 : MARKETING AND CRO PARTNERS OF CELLTRION IN VARIOUS COUNTRIES
  • Table 98 : BIOSIMILAR PIPELINE OF CELLTRION
  • Table 99 : BIOPHARMACEUTICALS DEVELOPED AND MARKETED BY BIOCAD
  • Table 100 : BIOSIMILAR PRODUCTS OF DONG-A PHARMACEUTICALS
  • Table 101 : BIOSIMILAR PRODUCTS MARKETED BY DR. REDDY'S LABORATORIES
  • Table 102 : BIOSIMILAR-RELATED INVESTMENTS BY HOSPIRA
  • Table 103 : BIOSIMILAR PIPELINE OF HOSPIRA
  • Table 104 : IBPL'S BIOSIMILAR PRODUCTS IN THE MARKET
  • Table 105 : MARKETING PARTNERSHIPS ESTABLISHED BY INTAS IN VARIOUS MARKETS
  • Table 106 : RECOMBINANT BIOSIMILAR PIPELINE OF JCR PHARMACEUTICALS
  • Table 107 : BIOLOGIC DRUGS DEVELOPED AND MARKETED BY LGLS
  • Table 108 : BIOSIMILAR PRODUCTS UNDER DEVELOPMENT BY NIPPON KAYAKU, JAPAN
  • Table 109 : BIOSIMILARS DEVELOPED AND MARKETED BY RELIANCE LIFE SCIENCES
  • Table 110 : PARTNERING COMPANIES INVOLVED IN THE ESTABLISHMENT OF SAMSUNG BIOLOGICS
  • Table 111 : MARKETED AND PIPELINE BIOSIMILAR PRODUCTS OF TEVA PHARMACEUTICALS
  • Table 112 : PARTNERING DEALS/ACQUISITIONS BY TEVA TARGETING THE DEVELOPMENT OF BIOPHARMACEUTICAL PIPELINE
  • Table 113 : BIOSIMILAR PRODUCTS MARKETED BY WOCKHARDT
  • Table 114 : GLOSSARY

List of Figures

  • Summary Figure : GLOBAL BIOSIMILAR DEMAND BY VALUE AND PRODUCT TYPE, 2011
  • Figure 1 : DEMAND TRENDS OF FILGRASTIM IN THE U.K. AFTER THE LAUNCH OF BIOSIMILARS, NOVEMBER. 2008-JUNE 2011
  • Figure 2 : THE JAPANESE BIOSIMILAR MARKET
  • Figure 3 : THE KOREAN BIOSIMILAR MARKET BY VALUE 2010-2016
  • Figure 4 : THE CHINESE BIOSIMILAR MARKET BY VALUE, 2010-2016
  • Figure 5 : THE INDIAN BIOSIMILAR MARKET BY VALUE, 2010-2016
  • Figure 6 : THE BIOSIMILAR MARKET FOR THE REST OF APAC, THROUGH 2016
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