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Market Research Report

Global Biosimilars and Follow-On Biologics Market 2019-2029: Monoclonal Antibodies (mAbs), Fusion Proteins, Insulin, Erythropoietins, Granulocyte Colony-Stimulating Factor (G-CSF), Interferons, Growth Hormones, Fertility Hormones

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Global Biosimilars and Follow-On Biologics Market 2019-2029: Monoclonal Antibodies (mAbs), Fusion Proteins, Insulin, Erythropoietins, Granulocyte Colony-Stimulating Factor (G-CSF), Interferons, Growth Hormones, Fertility Hormones
Published: March 21, 2019 Content info: 283 Pages
Description

The global biosimilars and follow-on biologics market is estimated to have reached $10.7bn in 2018 and expected to grow at a CAGR of 5.4% in the first half of the forecast period. The market is dominated by Biosimilar Monoclonal Antibodies, this submarket is estimated to hold 23% share of this market in 2018.

How this report will benefit you

Read on to discover how you can exploit the future business opportunities emerging in this sector.

In this brand new 283-page report you will receive 98 tables and 67 figures- all unavailable elsewhere.

The 283-page report provides clear detailed insight into the global biosimilars and follow-on biologics market. Discover the key drivers and challenges affecting the market.

By ordering and reading our brand-new report today you stay better informed and ready to act.

Report Scope

Global Biosimilars and Follow-on Biologics Market forecasts from 2019-2029

Along with revenue prediction for the overall world market for biosimilars, our investigation shows forecasts to 2029 for 8 individual therapeutic submarkets:

  • Monoclonal antibodies (mAbs)
  • Fusion proteins
  • Insulin
  • Erythropoietin (EPO)
  • Granulocyte colony-stimulating factor (G-CSF)
  • Interferons
  • Growth hormones
  • Fertility hormones

This report also shows revenue to 2029 for 12 individual submarkets within the above segments:

  • Rituximab, infliximab, trastuzumab, adalimumab and bevacizumab
  • Human insulin, insulin analogues, insulin glargine and insulin lispro
  • Interferon alfa and interferon beta
  • Etanercept

Our analyses show individual revenue forecasts to 2029 for 12 national markets:

  • US
  • Japan
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • China
  • India
  • South Korea
  • Russia
  • Brazil

Our study discusses the leading companies that are involved in the biosimilars and follow-on biologics industry

Our study provides a SWOT analysis of the biosimilars and follow-on biologics market.

Our study discusses pressures, opportunities and other events affecting the biosimilars industry and market, including these influences:

  • Strategies for developing biosimilars - needs, demand, challenges and opportunities
  • Guidelines from regulators (FDA, EMA and others)
  • Patent challenges and data exclusivity for biopharmaceuticals
  • Needs and opportunities in developing biosimilar mAbs, including rising incidence of cancers and increasing demand for lower-cost biologicals
  • Developments in technology and operations for biosimilar drug production.

Visiongain's study is intended for anyone requiring commercial analyses for the biosimilars and follow-on biologics market. You find data, trends and predictions.

Buy our report today Global Biosimilars and Follow-On Biologics Market 2019-2029: Monoclonal Antibodies (mAbs), Fusion Proteins, Insulin, Erythropoietins, Granulocyte Colony-Stimulating Factor (G-CSF), Interferons, Growth Hormones, Fertility Hormones.

Visiongain is a trading partner with the US Federal Government.

Table of Contents
Product Code: PHA0360

Table of Contents

1 Report Overview

  • 1.1 Biosimilar Overview
  • 1.2 Biosimilars Market Segmentation
  • 1.3 Why You Should Read this Report
  • 1.4 How this Report Delivers
  • 1.5 Main Questions Answered by this Report
  • 1.6 Who is this Report for?
  • 1.7 Research and Analysis Methods
  • 1.8 Frequently Asked Questions (FAQ)
  • 1.9 Some Associated Reports
  • 1.10 About Visiongain

2 An Introduction to Biosimilars and Biosimilar Drug Development

  • 2.1 What are Biologics?
    • 2.1.1 Biologics can be very effective but also very expensive
    • 2.1.2 Brief history of biological drug development
    • 2.1.3 Why are Biologics the most lucrative products in the global pharmaceutical market?
  • 2.2 What are Biosimilars?
  • 2.3 Brief History of Biosimilars
  • 2.4 What are Interchangeable Biological Products and how do They Differ from Biosimilars?
    • 2.4.1 FDA Guidelines on Prescription of Interchangeables vs Biosimilars
    • 2.4.2 Where does the EMA Stand with Regard to Interchangeables?
    • 2.4.3 Where do the EU5 and other European Countries Stand with Regard to Automatic Substitution?
    • 2.4.4 Why Would Nations Oppose Automatic Substitution of Reference Biologics with Biosimilars?
  • 2.5 Main Segments of the Overall Biosimilars Market

3 The Global Biosimilars Market 2018-2028

  • 3.1 The Global Biosimilars Market
  • 3.2 Biosimilars as a Share of the Biologics Market, 2017
    • 3.2.1 Seven of the Top Ten Best-Selling Drugs are Biologics
    • 3.2.2 Outlook for the Overall Biologics Market
  • 3.3 Global Biosimilars Market Forecast, 2017-2029
  • 3.4 What will Drive Growth in the Biosimilars Market?
    • 3.4.1 Health benefits associated with biosimilars
    • 3.4.2 Patent related re-issue factors
    • 3.4.3 Supportive government norms related to biosimilars
    • 3.4.4 Growing demand from emerging economies
    • 3.4.5 Increasing research and development activities
  • 3.5 What Factors Can Restrain Sales Growth in the Biosimilars Market?
    • 3.5.1 Complexity in development process
    • 3.5.2 Intense competition
    • 3.5.3 Availability of substitutes like biobetters and next-generation biologics
  • 3.6 Summary of the Drivers and Restraints for the Global Biosimilars Market
  • 3.7 Global Biosimilars Market Forecast by Submarket, 2017-2029
    • 3.7.1 Leading Segments in the Biosimilars Market
    • 3.7.2 How Will the Composition of the Market Change Over the Next Ten Years?

4 Outlook for Biosimilars in Leading Developed Markets, 2017-2029

  • 4.1 The Leading National Biosimilar Submarkets
  • 4.2 National Submarket Forecasts 2017-2029
  • 4.3 How will the Regional Composition of the Global Market Change from 2017-2029?
  • 4.4 US Biosimilars Market Outlook 2017-2029
    • 4.4.1 Status of the US Market in 2014-2018
    • 4.4.2 FDA Finalises Three New Guidelines on 351(k) Applications in April 2015
      • 4.4.2.1 The History of the US' Biosimilar Guidelines
    • 4.4.3 FDA Finally Releases Guidance on Biosimilar Naming
    • 4.4.4 Individual States Can Pass their Own Biosimilar Substitution Laws
    • 4.4.5 US Biosimilars Market Forecast 2017-2029
  • 4.5 The EU Biosimilar Market: History and Current Status
    • 4.5.1 History of EMA Guidelines and Updates
    • 4.5.2 Biosimilar Uptake in Europe Varies between Nations
    • 4.5.3 European Biosimilars Market Forecast, 2017-2029
    • 4.5.4 Inflectra and Remsima in Europe - Demonstrates a Path for Other Biosimilar mAbs
    • 4.5.5 German Biosimilar Market Outlook, 2018
      • 4.5.5.1 German Biosimilar Market Forecast, 2017-2029
    • 4.5.6 French Biosimilars Market Outlook, 2018
      • 4.5.6.1 Biosimilar Substitution Passed but Requires Decrees to Come into Effect, Expected Sometime This Year
      • 4.5.6.2 French Biosimilar Market Forecast, 2017-2029
    • 4.5.7 UK Biosimilar Market Outlook, 2018
      • 4.5.7.1 UK Biosimilar Market Forecast, 2017-2029
    • 4.5.8 Italian Biosimilars Market Outlook, 2018
      • 4.5.8.1 Italian Biosimilars Market Forecast, 2017-2029
    • 4.5.9 Spanish Biosimilars Market Outlook, 2018
      • 4.5.9.1 Spanish Biosimilar Market Forecast, 2017-2029
    • 4.5.10 Biosimilar Regulation in Japan and Currently Approved Biosimilars
      • 4.5.10.1 Differences between the European and Japanese Guidelines
      • 4.5.10.2 Currently Approved Biosimilars in Japan
      • 4.5.10.3 Japanese Biosimilar Market Forecast, 2017-2029

5 Outlook for Biosimilars in Emerging Markets, 2017-2029

  • 5.1 China and India Lead Biosimilar Revenues
  • 5.2 Leading Emerging Biosimilar Markets Forecast, 2017-2029
  • 5.3 Chinese Biosimilars Market Outlook, 2018
    • 5.3.1 China Publishes Final Guidelines for Biosimilars
    • 5.3.2 Biosimilars Account for less than Half of Biotech Revenues in China
    • 5.3.3 Chinese Biosimilars Market Forecast, 2017-2029
  • 5.4 Indian Biosimilars Market Outlook, 2018
    • 5.4.1 CDSCO Guidelines Released in 2012
    • 5.4.2 Indian Biosimilars Market Forecast, 2017-2029
  • 5.5 South Korea's Established Biosimilar Guidelines
    • 5.5.1 Currently Approved Biosimilars in South Korea, 2018
    • 5.5.2 South Korean Biosimilars Market Forecast, 2017-2029
  • 5.6 Russian Biosimilars Market Outlook and Forecast, 2017-2029
  • 5.7 Brazilian Biosimilar Regulation
    • 5.7.1 Government eager to promote biosimilar development, and two major conglomerates, bionovis and orygen, are racing to produce biosimilars
    • 5.7.2 Brazilian Biosimilars Market Forecast, 2017-2029

6 Biosimilar Monoclonal Antibodies: Submarket Forecast & Pipeline, 2017-2029

  • 6.1 MAbs as part of the overall biologics market in 2018
  • 6.2 Monoclonal Antibodies (mAbs): largest biologic submarket, with individual drugs accumulating multi-billion-dollar revenues
  • 6.3 Biosimilar Monoclonal Antibodies Market and Submarkets Forecast, 2017-2029
  • 6.4 Drivers for the Biosimilar Monoclonal Antibodies Market
    • 6.4.1 Product development on global scale
    • 6.4.2 Elevated count of cancer patients
    • 6.4.3 Rising need for cost effective treatments
    • 6.4.4 Formulation of business strategies
  • 6.5 Restraints for the Monoclonal Antibodies Market
    • 6.5.1 Availability of substitutes
      • 6.5.1.1 Growing demand for next-generation therapies
    • 6.5.2 Challenges in R&D process
    • 6.5.3 Patent related issues
  • 6.6 Leading Targets for Biosimilar Development, 2017-2029
  • 6.7 Biosimilar Rituximab
    • 6.7.1 Rituxan: The First Anti-Cancer mAb
    • 6.7.2 Approved Biosimilars and Rituxan Patent Expiry
      • 6.7.2.1 Reditux (Dr. Reddy's Laboratories): First Biosimilar Rituximab
      • 6.7.2.2 MabTas (Intas Pharmaceutical): Another Indian Biosimilar
      • 6.7.2.3 AcellBia (Biocad): The Leading Biosimilar Rituximab
      • 6.7.2.4 Kikuzubam (PROBIOMED) - Faced Challenges
    • 6.7.3 Biosimilar Rituximab Pipeline, 2017-2029
      • 6.7.3.1 Terminated Developments
      • 6.7.3.2 GP2013 (Sandoz): One of the Biggest Names in the Biosimilar Industry Throws its Hat into the Ring with Advanced Stage Candidate
      • 6.7.3.3 BI 695500 (Boehringer Ingelheim)
      • 6.7.3.4 MabionCD20 (Mabion): Focusing on Markets with High Demand
      • 6.7.3.5 CT-P10 (Celltrion)
      • 6.7.3.6 PF-05280586 (Pfizer)
    • 6.7.4 Biosimilar Rituximab: Revenue Forecast 2017-2029
  • 6.8 Biosimilar Infliximab
    • 6.8.1 Remicade: Second Only to Humira
    • 6.8.2 Approved Biosimilars and Remicade Patent Expiry: Uncertainty in the US after FDA Rejection
      • 6.8.2.1 Inflectra and Remsima (Hospira and Celltrion)
      • 6.8.2.2 Celltrion Speeds Ahead with US FDA Filing, and Inflectra Approved in Australia and Canada
      • 6.8.2.3 Inflimab and BOW015 (Epirus Biopharmaceuticals and Ranbaxy Laboratories)
    • 6.8.3 Biosimilar Infliximab Pipeline, 2017-2029
      • 6.8.3.1 SB2 (Samsung Bioepis): Has been filed for EU Approval and Shows Positive Phase 3 Results
      • 6.8.3.2 NI-071 (Nichi-Iko): Advanced Stages
      • 6.8.3.3 ABP 710 (Amgen) & BX2922 (BioXpress Therapeutics)
    • 6.8.4 Biosimilar Infliximab: Revenue Forecast 2017-2029
  • 6.9 Biosimilar Trastuzumab
    • 6.9.1 Herceptin: Another Jewel in Roche's Cancer mAb Portfolio
    • 6.9.2 Approved Biosimilars and Herceptin Patent Expiry
      • 6.9.2.1 Hertraz and CanMab (Mylan and Biocon): The First to Win Approval
      • 6.9.2.2 Herzuma (Celltrion)
    • 6.9.3 Biosimilar Trastuzumab Pipeline, 2017-2029
      • 6.9.3.1 BCD-022 (Biocad): Leading Biosimilar Rituximab Developer Tries its Hand at Trastuzumab
      • 6.9.3.2 ABP 980 (Amgen and Allergan): CHMP Approval
      • 6.9.3.3 PF-05280014 (Pfizer): FDA halts approval
      • 6.9.3.4 SB3 (Samsung Bioepis) and BX2318 (BioXpress Therapeutics)
    • 6.9.4 Biosimilar Trastuzumab: Revenue Forecast 2017-2029
  • 6.10 Biosimilar Adalimumab
    • 6.10.1 Humira - The World's Best-Selling Prescription Drug
    • 6.10.2 Approved Biosimilars and Humira Patent Expiry
      • 6.10.2.1 Exemptia (Zydus Cadila): The First Biosimilar Adalimumab
    • 6.10.3 Biosimilar Adalimumab Pipeline, 2017-2029
      • 6.10.3.1 ABP 501 (Amgen and Allergan): Positive Phase 3 Results Released
      • 6.10.3.2 GP2017 (Sandoz): Phase 3
      • 6.10.3.3 BI 695501 (Boehringer Ingelheim)
      • 6.10.3.4 SB5 (Samsung Bioepis)
    • 6.10.4 Biosimilar Adalimumab: Revenue Forecast 2017-2029
  • 6.11 Biosimilar Bevacizumab
    • 6.11.1 Avastin: High Revenues and Late Patent Expiry
    • 6.11.2 Biosimilar Bevacizumab Pipeline, 2017-2029
      • 6.11.2.1 BCD-021 (Biocad)
      • 6.11.2.2 ABP 215 (Amgen and Allergan): Approved
      • 6.11.2.3 BI 695502 (Boehringer Ingelheim): Phase 3
      • 6.11.2.4 PF-06439535 (Pfizer): Phase 3
    • 6.11.3 Biosimilar Bevacizumab: Revenue Forecast, 2017-2029

7 Biosimilar Fusion Proteins: Submarket Forecast and Pipeline, 2017-2029

  • 7.1 Scientific Background
  • 7.2 Differentiating Fusion Proteins
  • 7.3 Fusion Proteins as Part of the Overall Biologics Market
  • 7.4 Biosimilar Fusion Proteins Market Forecast, 2017-2029
  • 7.5 Biosimilar Etanercept, 2017-2029
    • 7.5.1 Enbrel is the Leading Fusion Protein
    • 7.5.2 Enbrel Granted Extended Patent Protection in the US, Patent has Expired in EU
    • 7.5.3 Multiple Biosimilars Available in Emerging Markets
      • 7.5.3.1 Brenzys / SB4 (Merck and Samsung Bioepis): First Product Approval to Result from Biosimilar Collaboration
      • 7.5.3.2 Yi Sai Pu (Shanghai CP Guojian Pharmaceutical) and Qiangke (Shanghai Celgen Biopharmaceutical)
      • 7.5.3.3 Etacept (Cipla) and Intacept (Intas Pharmaceuticals)
      • 7.5.3.4 Davictrel / HD-203 (Hanwha Chemical and Merck KGaA)
    • 7.5.4 Biosimilar Etanercept Pipeline
    • 7.5.5 GP2015 (Sandoz)
      • 7.5.5.1 Sandoz Goes in Early: FDA Accepts Application for GP2015, Despite the Fact that Enbrel Patents are not due to Expire any time soon
    • 7.5.6 SB4 (Samsung Bioepis): EMA Accepts Application
      • 7.5.6.1 Samsung Bioepis Releases Positive Phase 3 Data for SB4
    • 7.5.7 CHS-0214 (Coherus Biosciences and Baxter)
    • 7.5.8 TuNEX / ENIA11 (Mycenax Biotech / TSH Biopharm Corp): Phase 3 in Taiwan
    • 7.5.9 LBEC0101 (LG Life Sciences): Phase 3
    • 7.5.10 Biosimilar Etanercept: Revenue Forecast 2017-2029
  • 7.6 Eylea and Biosimilar Aflibercept
  • 7.7 Orencia and Biosimilar Abatacept

8 Biosimilar Insulin Submarket Outlook, 2017-2029

  • 8.1 Insulin as Part of the Biological Drug Sector
  • 8.2 30 Million People Expected to be diagnosed with Diabetes by 2030
  • 8.3 Approved Insulin Biosimilars
  • 8.4 Abasaglar / Basaglar / Insulin Glargine BS - The First Insulin Biosimilars to be approved in Developed Markets
  • 8.5 EMA Releases Finalised Insulin Biosimilars Guideline
  • 8.6 Basaglar Delayed in the US until End of 2016
  • 8.7 Biosimilar Insulin Market and Submarkets Forecast, 2017-2029
  • 8.8 Biosimilar Human Insulin Submarket, 2017-2029
    • 8.8.1 A Submarket Mostly Restricted to Emerging Markets?
    • 8.8.2 Biosimilar Human Insulin in China
    • 8.8.3 Biosimilar Human Insulin in India
      • 8.8.3.1 Wockhardt and Biocon - Given up on their Desire to Target the US and Europe?
    • 8.8.4 Biosimilar Human Insulin in Russia
    • 8.8.5 Biosimilar Human Insulin Submarket Forecast, 2017-2029
  • 8.9 Biosimilar Insulin Analogues Submarket, 2017-2029
    • 8.9.1 Available Biologic Insulin Analogues - Sanofi's Lantus Tops Revenues
    • 8.9.2 Insulin Glargine in the Main Biosimilar Target
      • 8.9.2.1 Limited Development for the Other Targets
    • 8.9.3 Insulin Market Leaders are Developing Ultra-Rapid Acting Insulin Analogues
      • 8.9.3.1 Ultra-Long Acting Insulin also in Development
    • 8.9.4 Mylan Partners with Biocon for Insulin Analogues
    • 8.9.5 Biosimilar Insulin Analogue Revenue Forecast, 2017-2029
  • 8.10 Biosimilar Insulin Glargine
    • 8.10.1 Biosimilars in India and China
    • 8.10.2 Biosimilar Insulin Glargine Pipeline
      • 8.10.2.1 MK-1293 (Merck / Samsung Bioepis)
      • 8.10.2.2 Mylan's Insulin Glargine (Mylan and Biocon)
    • 8.10.3 Biosimilar Insulin Glargine: Revenue Forecast, 2017-2029
  • 8.11 Biosimilar Insulin Lispro
    • 8.11.1 Currently Available Biosimilars
    • 8.11.2 Much Smaller Pipeline than for Insulin Glargine
    • 8.11.3 Biosimilar Insulin Lispro: Revenue Forecast, 2017-2029

9 Biosimilar Erythropoietins Submarket Outlook, 2017-2029

  • 9.1 Three Products Lead the Biologic EPO Therapy Market
  • 9.2 Safety Concerns for Erythropoietin-Stimulating Agents
  • 9.3 The Challenge from Oral Therapies is coming
  • 9.4 Treating Anaemia in Patients with CKD - the Leading Use of EPO Therapies
  • 9.5 Biosimilar Epoetin Approvals in Europe
  • 9.6 Epoetin Alfa Pipeline for the European Market
  • 9.7 Trends in Uptake for Biosimilar Epoetins in Europe
  • 9.8 Epoetin Alfa Pipeline for the US - Companies Preparing for Launch
    • 9.8.1 Pfizer's Retacrit Delayed after Response Letter from FDA
    • 9.8.2 Binocrit / HX575 has Completed Trials
  • 9.9 Biosimilar Epoetin in Japan
  • 9.10 Biosimilar Epoetin in South Korea
  • 9.11 Biosimilar Epoetin in India and China
  • 9.12 Second-Generation EPO Biosimilars
  • 9.13 No Mircera Biosimilars in Clinical Development
  • 9.14 Biosimilar EPO Market Forecast, 2017-2029

10 Biosimilar G-CSF Submarket Outlook, 2017-2029

  • 10.1 Amgen Leads the Branded Biologic G-CSF Market
  • 10.2 Teva Launches Long-Acting Pegfilgrastim
  • 10.3 Selected Filgrastim Biosimilars Approved Worldwide
    • 10.3.1 The European G-CSF Biosimilars Market
      • 10.3.1.1 Trends in Biosimilar Uptake across Europe
    • 10.3.2 Tevagrastim (Teva): The First Biosimilar in Europe, Launched as Granix in the US
    • 10.3.3 Nivestim (Hospira - Pfizer)
    • 10.3.4 Zarzio (Sandoz): The Most Prescribed Biosimilar Therapy in Europe
    • 10.3.5 Zarxio Becomes the First Biosimilar to be Approved in the US, Launched in September
    • 10.3.6 Apotex: FDA has Accepted Applications for both its Biosimilar Filgrastim, and its Biosimilar Pegfilgrastim
    • 10.3.7 Multiple Launches in Japan in Recent Years
    • 10.3.8 Biosimilar Filgrastim and Pegfilgrastim in India
    • 10.3.9 Biosimilars in Russia, China and Other Emerging Markets
  • 10.4 Biosimilar G-CSF Market Forecast, 2017-2029

11 Biosimilar Interferons Submarket Outlook, 2017-2029

  • 11.1 Interferons: Key Antiviral and MS Therapies since the 1990s
  • 11.2 Leading Interferon Brands
  • 11.3 Competition for the Multiple Sclerosis Market - Challenges for Interferon Beta Therapies
  • 11.4 All-Oral Regimens will Challenge Interferon Alfa Therapy
    • 11.4.1 However Oral Therapies will be Expensive
  • 11.5 There are no Approved Biosimilars in Developed Markets
  • 11.6 Biosimilar Interferon Market Forecast, 2017-2029
  • 11.7 Biosimilar Interferon Alfa
    • 11.7.1 Biosimilar Interferon Alfa - a Common Target in Developing Countries, Leading to Fragmented Markets
    • 11.7.2 Biosimilar Peginterferon Alfa
    • 11.7.3 Hepatitis Treatment Rates are Low
    • 11.7.4 Biosimilar Interferon Alfa Submarket Forecast, 2017-2029
  • 11.8 Biosimilar Interferon Beta
    • 11.8.1 Biosimilars are Well-Established in Emerging Markets
    • 11.8.2 Biosimilar Interferon Beta Pipeline
    • 11.8.3 EMA Guidance
    • 11.8.4 Long-Acting Interferon Beta
    • 11.8.5 Biosimilar Interferon Beta Submarket Forecast, 2017-2029

12 Biosimilar Recombinant Hormones Submarket Outlook, 2017-2029

  • 12.1 Human Growth Hormone: First Extracted in 1958
  • 12.2 Biologic Growth Hormone Market in 2014 - Novo Nordisk and Pfizer Dominate
    • 12.2.1 Novo Nordisk Aiming to Retain Dominance through FlexPro Device and NN8640 Somatropin Candidate
  • 12.3 Biosimilar Growth Hormones
    • 12.3.1 Omnitrope - Well Established in Developed Markets
  • 12.4 Multiple Biosimilars Available Worldwide
    • 12.4.1 Biosimilars Growth Hormones Outside of Asia
    • 12.4.2 Biosimilar Growth Hormones in Asia
    • 12.4.3 Biosimilar Uptake Varies by Region
  • 12.5 Biosimilar Growth Hormones Market Forecast, 2017-2029
  • 12.6 Fertility Hormones
    • 12.6.1 Two Products Lead the Branded Fertility Hormone Market
    • 12.6.2 Long-Acting Follicle Stimulating Hormone (FSH)
    • 12.6.3 Branded Fertility Hormones Market Outlook
    • 12.6.4 Available Biosimilar Fertility Hormones
    • 12.6.5 Biosimilars Approved in Europe
      • 12.6.5.1 Ovaleap (Teva)
      • 12.6.5.2 Befomla (Finox Biotech) Approved in Europe, Undergoing Phase 3 for US
    • 12.6.6 Rising Infertility to Drive Demand to 2028
    • 12.6.7 Biosimilar Fertility Hormones Market Forecast, 2017-2029

13 Biosimilars: Qualitative Analysis and Industry Trends

  • 13.1 SWOT Analysis of the Biosimilars Market
  • 13.2 Biosimilars Market: Strengths
    • 13.2.1 Cost effective nature
    • 13.2.2 Adoption of biosimilars in developed region
    • 13.2.3 Well established market
    • 13.2.4 Outsourcing factors
  • 13.3 Biosimilars Market: Weaknesses
    • 13.3.1 High capital investment
    • 13.3.2 Complex development procedure
    • 13.3.3 Low demand from some regions
  • 13.4 Biosimilars Market: Opportunities
    • 13.4.1 Patent re-new factor
    • 13.4.2 Increasing disease prevalence
    • 13.4.3 Licensing Agreements
  • 13.5 Threats
    • 13.5.1 Alternative markets
    • 13.5.2 Patent Issues
    • 13.5.3 Market fragmentation
    • 13.5.4 Long Market and Data Exclusivity Periods
    • 13.5.5 Lack of marketing
  • 13.6 Biosimilars Product Pipeline

14 Company Profiles

  • 14.1 Amgen Inc.
  • 14.2 Biocon Limited
  • 14.3 Celltrion Healthcare Co. Ltd.
  • 14.4 Dong-A Socio Holdings
  • 14.5 Dr. Reddy's Laboratories Ltd.
  • 14.6 F Hoffmann-La Roche Ltd.
  • 14.7 Pfizer Inc.
  • 14.8 Stada Arzneimittel AG
  • 14.9 Teva Pharmaceutical Industries Ltd.
  • 14.10 Wockhardt Limited

15 Conclusions from Visiongain's Research and Analysis

  • 15.1 Rapid Growth Expected for this High-Potential Market
  • 15.2 Biosimilar Monoclonal Antibodies to be the Fastest Growing Segment
  • 15.3 A Range of Factors Will Stimulate Demand
  • 15.4 Challenges Remain in Developing and Successfully Launching Biosimilars
  • Appendices
  • Some Associated Reports
  • Visiongain Report Sales Order Form
  • Appendix A
  • About Visiongain
  • Appendix B
  • Visiongain report evaluation form

List of Tables

  • Table 2.1 First Approvals for Recombinant Protein Therapies, 1982-1993
  • Table 3.1 Top Ten Best-Selling Drugs of 2017 (Within Overall Pharmaceutical Market): Revenues ($bn), Market Shares (%)
  • Table 3.2 Global Biosimilars Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 3.3 Patent Status for Leading Biologics within the Overall Biologics Market, 2018
  • Table 3.4 Biosimilars Market Forecast by Product Type: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 4.1 Global Biosimilars Market by Region: Revenues ($bn), Market Share (%), 2018
  • Table 4.2 Biosimilars Market Forecast by Nations: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 4.3 U.S. Biosimilar Approvals To-Date, 2018
  • Table 4.4 US Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 4.5: European Biosimilar Approvals To-Date, 2018
  • Table 4.6 European Biosimilar Market Segmented by Leading Nations: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 4.7 Germany Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 4.8 France Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 4.9 UK Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 4.10 Italy Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 4.11 Spain Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 4.12 Japanese Biosimilar Approvals To-Date, 2018
  • Table 4.13 Japan Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 5.1 Leading Emerging Biosimilar Markets: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2017-2029
  • Table 5.2 China Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 5.3 India Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 5.4 Currently Approved Biosimilars in South Korea, 2016
  • Table 5.5 South Korea Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 5.6 Russia Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 5.7 Brazil Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 6.1 The Best-Selling mAbs of 2017: Revenue ($bn), 2017
  • Table 6.2 Biosimilar Monoclonal Antibodies Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 6.3 Biosimilar Monoclonal Antibodies Market and Submarkets Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 6.4 Patent Status of Five Leading mAbs, 2018
  • Table 6.5 Patent Status of Five Leading mAbs, 2018
  • Table 6.6 Past and Present GP2013 (Sandoz)Clinical Trials, 2018
  • Table 6.7 Ongoing BI 695500 (Boehringer Ingelheim) Clinical Trials, 2018
  • Table 6.8 Ongoing CT-P10 (Celltrion) Clinical Trials, 2018
  • Table 6.9 Past and Present PF-05280586 (Pfizer) Clinical Trials, 2018
  • Table 6.10 Biosimilar Rituximab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 6.11 Biosimilar Infliximab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 6.12 Ongoing PF-05280014 (Pfizer) Clinical Trials, 2018
  • Table 6.13 Biosimilar Trastuzumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 6.14 Recent ABP 501 (Amgen and Allergan) Clinical Trials, 2018
  • Table 6.15 Ongoing BI 695501 (Boehringer Ingelheim) Clinical Trials, 2018
  • Table 6.16 Biosimilar Adalimumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 6.17 Recent BCD-021 (Biocad) Clinical Trials, 2018
  • Table 6.18 Biosimilar Bevacizumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 7.1 Biosimilar Fusion Proteins Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 7.2 Amgen's US Patents and Expiry Dates for Enbrel
  • Table 7.3 Ongoing CHS-0214 (Coherus Biosciences and Baxter) Clinical Trials, 2018
  • Table 7.4 Biosimilar Etanercept Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2028
  • Table 8.1 Biosimilar Diabetes Prevalence in Leading National Markets, 2012
  • Table 8.2 Selected Insulin Biosimilars which have been Approved and Launched
  • Table 8.3 Biosimilar Insulin Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 8.4 Biosimilar Insulin Market and Submarkets Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 8.5 Biosimilar Human Insulin Submarkets Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 8.6 Approved Insulin Analogues Marketed Worldwide, 2018
  • Table 8.7 Biosimilar Insulin Analogues Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 8.8 MK-1293 (Merck / Samsung Bioepis) Recent Clinical Trials, 2018
  • Table 8.9 Insulin Glargine Biosimilar (Mylan and Biocon) Ongoing Clinical Trials, 2018
  • Table 8.10 Biosimilar Insulin Glargine Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 8.11 Biosimilar Insulin Lispro Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 9.1 Ongoing ASP1517 (Astellas Pharma) Clinical Trials, 2018
  • Table 9.2 Binocrit / HX575 (Novartis) Clinical Trials, 2018
  • Table 9.3 Selected EPO Biosimilars Approved in India
  • Table 9.4 Biosimilar EPO Market Forecast: Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2017-2029
  • Table 10.1 Selected Filgrastim Biosimilars Approved Worldwide
  • Table 10.2 Biosimilar G-CSF Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 11.1 Types of Interferon Used Therapeutically, 2018
  • Table 11.2 Approved Branded Interferon Therapies, 2018
  • Table 11.3 Biosimilar Interferons Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 11.4 Selected Interferon Alfa Biosimilars Approved Worldwide, 2018
  • Table 11.5 Chronic Hepatitis B and C: Global Prevalence by Region, 2014
  • Table 11.6 Biosimilar Interferon Alfa Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 11.7 Selected Interferon Beta Biosimilars Approved Worldwide
  • Table 11.8 Biosimilar Interferon Alfa Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 12.1 Biosimilar Growth Hormone Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 12.2 Recent Bemfola / Afolia (Finox Biotech) Clinical Trials, 2018
  • Table 12.3 Biosimilar Fertility Hormone Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2017-2029
  • Table 13.1 Expected Biologic Patent Expiries, 2016-2029
  • Table 13.2 Typical Models of Collaboration for Biosimilar Development
  • Table 13.3 Biosimilars product pipeline
  • Table 14.1 Amgen Inc. Profile 2017
  • Table 14.2 Amgen: Key Developments
  • Table 14.3 Biocon Limited Profile 2018
  • Table 14.4 Biocon Limited: Key Developments
  • Table 14.5 Celltrion Healthcare Co. Ltd. Profile 2017
  • Table 14.6 Celltrion Healthcare: Key Developments
  • Table 14.7 Dong-A Socio Holdings Profile 2018
  • Table 14.8 Dong-ASocio Holdings: Key Developments
  • Table 14.9 Dr. Reddy's Laboratories Ltd. Profile 2017
  • Table 14.10 Dr. Reddy's Laboratories: Key Developments
  • Table 14.11 F Hoffmann-La Roche Ltd. Profile 2018
  • Table 14.12 Pfizer Inc. Profile 2017
  • Table 14.13 Stada Arzneimittel AG Profile 2017
  • Table 14.14 Stada: Key Developments
  • Table 14.15 Teva Pharmaceutical Industries Ltd. Profile 2018
  • Table 14.16 Teva: Key Developments
  • Table 14.17 Wockhardt Limited Profile 2018
  • Table 14.18 Wockhardt Limited: Key Developments
  • Table 15.1 Biosimilars and Follow-On Biologics Market: Revenue ($bn) and Market Share (%) by Sector, 2018, 2022 and 2028
  • Table 15.2 Biosimilars and Follow-On Biologics Market: Revenue ($bn) and Market Share (%) by Region, 2018, 2022 and 2028

List of Figures

  • Figure 1.1 Main Segments and Sub-Segments of the Biosimilars Market, 2018
  • Figure 3.1 Biosimilars Market as Share of the Overall Biologics Market: Market Share (%), 2017
  • Figure 3.3 Global Biosimilars Market Forecast: Revenue ($bn), 2017-2029
  • Figure 3.4 Drivers and Restraints for the Biosimilars Market, 2018
  • Figure 3.5 Global Biosimilars Market Forecasts by Submarket: Revenue ($bn), 2017-2029
  • Figure 3.6 Composition of the Biosimilars Market in 2018: Market Shares (%)
  • Figure 3.7 Composition of the Biosimilars Market in 2022: Market Shares (%)
  • Figure 3.8 Composition of the Biosimilars Market in 2028: Market Shares (%)
  • Figure 4.1 Regional Composition of the Biosimilars Market in 2018: Market Shares (%)
  • Figure 4.2 Global Biosimilars Market Forecasts by Nations: Revenue ($bn), 2017-2029
  • Figure 4.3 Regional Composition of the Biosimilars Market in 2018: Market Shares (%)
  • Figure 4.4 Regional Composition of the Biosimilars Market in 2022: Market Shares (%)
  • Figure 4.5 Regional Composition of the Biosimilars Market in 2028: Market Shares (%)
  • Figure 4.6 US Biosimilars Market: Revenue ($bn), 2017-2029
  • Figure 4.7 European Biosimilars Market Breakdown: Revenue ($bn), 2018
  • Figure 4.8 European Biosimilars Market Breakdown: Revenue ($bn), 2022
  • Figure 4.9 European Biosimilars Market Breakdown: Revenue ($bn), 2028
  • Figure 4.10 European Biosimilars Market Segmented by Leading Nations: Revenue ($bn), 2017-2029
  • Figure 4.11 Germany Biosimilars Market: Revenue ($bn), 2017-2029
  • Figure 4.12 France Biosimilars Market: Revenue ($bn), 2017-2029
  • Figure 4.13 UK Biosimilars Market: Revenue ($bn), 2017-2029
  • Figure 4.14 Italy Biosimilars Market: Revenue ($bn), 2017-2029
  • Figure 4.15 Spain Biosimilars Market: Revenue ($bn), 2017-2029
  • Figure 4.16 Japan Biosimilars Market: Revenue ($bn), 2017-2029
  • Figure 5.1 Leading Emerging Nations Biosimilar Market Shares: Revenues ($bn), 2018
  • Figure 5.2 Leading Emerging Nations Biosimilar Market Shares: Revenues ($bn), 2022
  • Figure 5.3 Leading Emerging Nations Biosimilar Market Shares: Revenues ($bn), 2028
  • Figure 5.4 Leading Emerging Nations Biosimilar Market Shares: Revenues ($bn), 2017-2029
  • Figure 5.5 China Biosimilars Market: Revenue ($bn), 2017-2029
  • Figure 5.6 India Biosimilars Market: Revenue ($bn), 2017-2029
  • Figure 5.7 South Korea Biosimilars Market: Revenue ($bn), 2017-2029
  • Figure 5.8 Russia Biosimilars Market: Revenue ($bn), 2017-2029
  • Figure 6.1 Monoclonal Antibodies in the Total Biologics Market: Revenue ($bn), 2018
  • Figure 6.2 The Best-Selling mAbs of 2017 as a Percentage of the Total Biologics Market: Revenue ($bn), Market Share (%), 2017
  • Figure 6.3 Biosimilar Monoclonal Antibodies Market Forecast: Revenue ($bn), 2017-2029
  • Figure 6.4 Biosimilar Monoclonal Antibody Market Forecast, Split by Product: Revenue ($bn), 2017-2029
  • Figure 6.5 Biosimilar Rituximab Revenue Forecast: Revenue ($bn), 2017-2029
  • Figure 6.6 Biosimilar Infliximab Revenue Forecast: Revenue ($bn), 2017-2029
  • Figure 6.7 Biosimilar Trastuzumab Revenue Forecast: Revenue ($bn), 2017-2029
  • Figure 6.8 Biosimilar Adalimumab Revenue Forecast: Revenue ($bn),2017-2029
  • Figure 6.9 Biosimilar Bevacizumab Revenue Forecast: Revenue ($bn), 2017-2029
  • Figure 7.1 Fusion Proteins in the Total Biologics Market: Revenue ($bn), Market Share (%), 2017
  • Figure 7.2 Biosimilar Fusion Proteins Revenue Forecast: Revenue ($bn), 2017-2029
  • Figure 7.3 Biosimilar Etanercept Market Forecast: Revenue ($bn), 2016-2028
  • Figure 8.1 Diabetes Prevalence in Leading National Markets, 2012
  • Figure 8.2 Biosimilar Insulin Market Forecast: Revenue ($bn), 2017-2029
  • Figure 8.3 Biosimilar Insulin Submarket Forecast: Revenue ($bn), 2017-2029
  • Figure 8.4 Drivers and Restraints for the Biosimilar Insulin Market, 2018
  • Figure 8.5 Biosimilar Human Insulin Submarket Revenue Forecast: Revenue ($bn), 2017-2029
  • Figure 8.6 Biosimilar Insulin Analogues Market Forecast: Revenue ($bn), 2017-2029
  • Figure 8.7 Biosimilar Insulin Glargine Revenue Forecast: Revenue ($bn), 2017-2029
  • Figure 8.8 Biosimilar Insulin Submarket Forecast: Revenue ($bn), 2017-2029
  • Figure 9.1 Biosimilar EPO Market Forecast: Revenue ($bn), 2017-2029
  • Figure 10.1 Biosimilar G-CSF Market Forecast: Revenue ($bn), 2017-2029
  • Figure 11.1 Biosimilar Interferons Market Forecast: Revenue ($bn), 2017-2029
  • Figure 11.2 Chronic Hepatitis B: Global Prevalence (Million) by Region, 2014
  • Figure 11.3 Chronic Hepatitis C: Global Prevalence (%) by Region, 2014
  • Figure 11.4 Biosimilar Interferon Alfa Market Forecast: Revenue ($bn), 2017-2029
  • Figure 11.5 Biosimilar Interferon Alfa Market Forecast: Revenue ($bn), 2017-2029
  • Figure 12.1 Global Biosimilars Market Forecasts by Submarket: Revenue ($bn), 2017-2029
  • Figure 12.2 Biosimilar Fertility Hormone Market Forecast: Revenue ($bn), 2017-2029
  • Figure 13.1 Strengths and Weaknesses of the Biosimilars Market, 2017-2029
  • Figure 13.2 Opportunities and Threats for the Biosimilars Market, 2017-2029
  • Figure 13.3 Biosimilar Development Costs by Stage, 2018
  • Figure 13.4 Typical Biosimilar Development Timeline
  • Figure 15.1 Biosimilars and Follow-On Biologics Market: Revenue ($bn), by Sector, 2018, 2022 and 2028
  • Figure 15.2 Biosimilars and Follow-On Biologics Market: Revenue ($bn), by Region, 2018, 2022 and 2028

COMPANIES LISTED:

  • Allergan
  • Allozyne
  • Alteogen
  • Alvogen
  • Amarey Novamedical
  • Amega Biotech
  • Amgen
  • Apotex
  • Astellas Pharma
  • AstraZeneca
  • Avesthagen
  • Baxter
  • Bayer
  • Beijing Four Rings
  • Beijing SL Pharmaceutical
  • Biocad
  • Bioceuticals
  • Biocon Limited
  • Biogen
  • BioGenomics
  • Biolab
  • Bionovis
  • BioPartners
  • Biosidus
  • Bioton
  • BioXpress Therapeutics
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Cambridge Antibody Technology
  • CCL Pharmaceuticals
  • CCM Duopharma
  • Celltrion
  • Centocor Ortho Biotech
  • Chong Kun Dang
  • Chugai
  • CinnaGen.
  • Coherus BioSciences
  • Compass Biotechnologies
  • Cristália
  • CT Arzneimittel
  • Cyplasin
  • Daiichi Sankyo
  • Dong-A Pharmaceutical
  • Dong-A Socio Holdings
  • Dr. Reddy's Laboratories
  • Egis Pharmaceuticals
  • Eisai
  • Eli Lilly
  • Elpen Pharmaceutical
  • Emcure Pharmaceuticals
  • EMS
  • Epirus
  • Eurofarma
  • Express Scripts
  • FibroGen
  • Finox Biotech
  • Fuji Pharma
  • Gan & Lee
  • Genetech
  • Genexine
  • Gennova
  • GenSci
  • Genzyme
  • Geropharm
  • Gilead Sciences
  • GlaxoSmithKline
  • Hangzhou Jiuyuan Gene Engineering Co.
  • Hanmi Pharmaceutical
  • Hanwha Chemical
  • Haselmeier
  • Health Canada
  • Helius Biotech
  • Hexal
  • Hindustan Antibiotic
  • Hospira
  • Hualida Biotech
  • Hypermarcas
  • IGES Institute
  • Intas Biopharmaceuticals
  • inVentiv Health
  • JCR Pharmaceuticals
  • Johnson & Johnson
  • Kabi
  • Kemwell Biopharma
  • Kissea
  • Koçak Farma
  • Kwizda Pharma
  • Kyowa Hakko Kirin
  • Landsteiner Scientific
  • LG Life Sciences
  • Libbs
  • LKM SA
  • Lonza
  • Mabion
  • Marvel Life Sciences
  • MEDICE Arzneimittel Pütter
  • Merck (MSD)
  • Merck KGaA
  • Merck Serono
  • Minapharm
  • Mitsubishi Tanabe
  • Mochida Pharmaceutical
  • Momenta Pharmaceuticals
  • Mycenax Biotech
  • Mylan
  • Nichi-Iko
  • Nippion Kayaku
  • Novartis
  • Novo Nordisk
  • Nuron Biotech
  • Oncobiologics
  • Ortho Pharmaceutical
  • Orygen
  • PanGen Biotech
  • Pfenex
  • Pfizer
  • Pharmapark
  • Pharmstandard
  • PRA International
  • Pro Generika
  • PROBIOMED
  • Qilu Pharmaceutical
  • Quintiles
  • Ranbaxy Laboratories
  • RAND Corporation
  • Ratiopharm
  • Regeneron Pharmaceuticals
  • Reliance GeneMedix
  • Reliance Life Sciences (RLS)
  • Rentschler Biotechnologie
  • Roche
  • Samsung Bioepis
  • Samsung BioLogics
  • Sandoz
  • Sanofi
  • SciGen
  • Shandong Kexing Pharma
  • Shanghai Celgen Biopharmaceutical
  • Shanghai CP Guojian
  • Shanghai Fosun
  • Shantha Biotechnics
  • Shinogi
  • Sicor Biotech
  • Sothema Laboratories
  • Spectrum Pharmaceuticals
  • STADA Arzneimittel
  • Stragen Pharma
  • Strides Arcolab
  • Syngene International
  • Synthon Biopharmaceuticals
  • Takeda
  • Teva
  • Tianjin Hualida Biotechnology
  • Tonghua Dongbao
  • TSH Biopharm Corp
  • União Química
  • USV Biologics
  • Virchow Biotech
  • Wanbang Biopharmaceuticals
  • Wockhardt
  • Xiamen Amoytop Biotech
  • Zenotech
  • Zhejian Huahai Pharmaceutical
  • Zuventus
  • Zydus Biovation
  • Zydus Cadila

List of Organisations Mentioned in the Report:

  • Argentine Ministry of Health
  • Cardiovascular and Renal Drugs Advisory Committee
  • Cardiovascular Drugs Advisory Committee
  • Centers of Medicare and Medicaid Services (CMS)
  • Central Drugs Standard Control Organisation
  • Centre for Drug Evaluation (CDE)
  • China Food and Drug Administration
  • Comisión Federal para la Protección contra Riesgos Sanitarios
  • Committee for Medicinal Products for Human Use
  • European Generic Medicines Association (EGA)
  • European Medicines Agency (EMA)
  • Intellectual Property Appellate Board (IPAB)
  • Korea Food and Drug Administration
  • Mexican Supreme Court
  • Ministry for Health Labour and Welfare (MHLW)
  • National Health Service (NHS)
  • National Institute for Health and Care Excellence (NICE)
  • Norwegian Ministry of Health
  • Pan American Health Organization
  • Pharmaceuticals and Medical Devices Agency (PMDA)
  • Russian Ministry of Health
  • Scottish Medicines Consortium (SMC)
  • Stanford University
  • State Employees' Social Security and Social Services Institute (ISSSTE)
  • The Brazilian Ministry of Health
  • The Drug Regulatory Authority of Pakistan
  • The Ministry of Food and Drug Safety (MFDS)
  • The National Conference of State Legislatures (US)
  • The United Laboratories (TUL)
  • Therapeutic Goods Administration
  • Toronto University
  • UK Medicines and Healthcare Products Regulatory Agency (MHRA)
  • University of California, San Francisco
  • University of Tokyo
  • US Center for Disease Prevention and Control (CDC)
  • US Court of Appeals
  • US Food and Drug Administration (FDA)
  • US Patent and Trademark Office
  • World Health Organization (WHO)
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