Global & USA BioSimilar Market Analysis to 2021

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BioBetters, Erythropoietin (EPO), Human Growth Hormone (HGH), Granulocyte Colony-Stimulating Factor (G-CSF), Anti-Tumor Necrosis Factor (Anti-TNF), Monoclonal Antibodies (MAbs), Insulins, Interferons, Product Pipelines, Trends, Key Players, Regulations and Strategic Outlook

Published Jan 2016

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Published Jan 2016; Sample pages here

This report provides a comprehensive overview of the size of biosimilars’ market, the segmentation of the market, key players and the vast potential of therapies that are in clinical trials. In total, 44 biosimilars are available in the global market and currently the E.U. is the major market with 19 approved biosimilars in use. A significant number of biosimilars are available in the markets of China, India, South Korea and Latin America. Biosimilars from these emerging countries are approved by a less-stringent approval pathway and therefore, the commercialization of their products is mostly confined to the domestic markets. The report describes how the long-awaited FDA approval of Zarxio from Sandoz (biosimilar for Amgen’s Neupogen) in March 2015 is to transform the otherwise nascent market. The report includes:

 

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

 

1.3       Key Questions Answered in This Report

 

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

 

Table of Contents

 

1.0….. Introduction……………………………………………………………………………………………………………………………………………………… ..

1.1….. Executive Summary………………………………………………………………………………………………………………………………………… ..

1.2….. Objectives of This Report………………………………………………………………………………………………………………………………… ..

1.3….. Key Questions Answered in This Report………………………………………………………………………………………………………… ..

2.0….. Biosimilars: A Brief Overview………………………………………………………………………………………………………………………… ..

2.1….. Biologic Drugs………………………………………………………………………………………………………………………………………………… ..

2.1.1.. Development of Biologics………………………………………………………………………………………………………………………………. ..

2.1.2.. Biologics vs. SMDs………………………………………………………………………………………………………………………………………… ..

2.2….. Biosimilar Drugs……………………………………………………………………………………………………………………………………………… ..

2.2.1.. Definition of Biosimilars by The WHO, EMA and FDA……………………………………………………………………………….. ..

2.2.2.. Quality Safety and Efficacy (QSE) Assessment of Biosimilars……………………………………………………………………… ..

2.2.3.. Differences between Biosimilars and Biologics…………………………………………………………………………………………….. ..

2.2.4.. Variations in Development Efforts for Biosimilars, Biologics and Generics…………………………………………………. ..

2.2.5.. Barriers in Developing Identical Copies of Biologics…………………………………………………………………………………….. ..

2.2.6.. The Cost of Developing Biosimilars………………………………………………………………………………………………………………. ..

2.2.7.. Roadmap to a Biosimilar………………………………………………………………………………………………………………………………… ..

2.2.8.. The Emerging Role of Biosimilars…………………………………………………………………………………………………………………. ..

2.2.9.. Different Names for Biosimilars…………………………………………………………………………………………………………………….. ..

3.0….. Regulations for Biosimilars: An Overview……………………………………………………………………………………………………… ..

3.1….. Biosimilar Drug Registrations in Europe………………………………………………………………………………………………………… ..

3.1.1.. Rules against Automatic Substitution of Biosimilars in E.U. Member States………………………………………………… ..

3.1.2.. Shareholders’ Attitudes towards Biosimilars in Europe…………………………………………………………………………………. ..

3.2….. Biosimilar Guidelines in China……………………………………………………………………………………………………………………….. ..

3.3….. Regulatory Pathway for the Approval of Biosimilars in India………………………………………………………………………… ..

3.4….. Regulatory Pathway for the Approval of Biosimilars in the U.S…………………………………………………………………….. ..

3.4.1.. U.S. Regulation on Interchangeability of Biosimilars……………………………………………………………………………………. ..

3.4.2.. Extrapolation for Biosimilars in the U.S………………………………………………………………………………………………………… ..

3.4.3.. Totality of Evidence Approach for Biosimilar Approval by FDA………………………………………………………………….. ..

3.4.4.. Evaluation of Immunogenicity in all Stages of Biosimilar Development………………………………………………………. ..

3.4.5.. Timeline of U.S. Biosimilar Guideline Evolution, 2010-2015………………………………………………………………………… ..

3.5….. Regulations Regarding the Use of Reference Products by Country………………………………………………………………… ..

3.6….. Regulations Regarding Extrapolation by Country…………………………………………………………………………………………… ..

3.7….. Regulations Regarding Clinical Studies by Country……………………………………………………………………………………….. ..

3.8….. Regulations Regarding Interchangeability by Country……………………………………………………………………………………. ..

3.9….. Regulations Regarding Unique Naming by Country……………………………………………………………………………………….. ..

4.0….. Development of Biosimilars: An Overview…………………………………………………………………………………………………….. ..

4.1….. Unmet Need for Biosimilars……………………………………………………………………………………………………………………………. ..

4.2….. Stages in the Development of Biosimilars………………………………………………………………………………………………………. ..

4.2.1.. Developing a Highly Similar Product…………………………………………………………………………………………………………….. ..

4.2.2.. Confirming Biosimilarity……………………………………………………………………………………………………………………………….. ..

4.3….. Biosimilar Development Stages………………………………………………………………………………………………………………………. ..

4.4….. Capabilities Required for a Successful Biosimilar Developer…………………………………………………………………………. ..

4.4.1.. Manufacturing Capabilities…………………………………………………………………………………………………………………………….. ..

4.4.2.. Clinical Development Experience and Regulatory Know-How……………………………………………………………………… ..

4.4.3.. Customized Sales and Marketing Skills…………………………………………………………………………………………………………. ..

4.4.4.. Long-Term Biosimilar Strategy……………………………………………………………………………………………………………………… ..

4.4.5.. Upfront Capital Investment…………………………………………………………………………………………………………………………….. ..

4.5….. Types of Firms Participating in Biosimilar Development……………………………………………………………………………….. ..

4.6….. Key Markets with Biosimilar Approval Pathways…………………………………………………………………………………………… ..

4.7….. Success Rates in the Development of Biosimilar Drugs………………………………………………………………………………….. ..

4.8….. The Most Popular Biosimilar Targets……………………………………………………………………………………………………………… ..

4.8.1.. Total Number Biosimilars in Development for the Corresponding Biologics………………………………………………… ..

4.8.1.1 Biosimilars in Development for Originator Avastin (Bevacizumab)……………………………………………………………… ..

4.8.1.2Biosimilars in Development for Originator Enbrel (Etanercept)…………………………………………………………………….. ..

4.8.1.3  Biosimilars in Phase III Development for Herceptin (Trastuzumab)…………………………………………………………….. ..

4.8.1.4 Biosimilars in Development for Humira (Adalimumab)………………………………………………………………………………… ..

4.8.1.5 Biosimilars in Development for Neulasta (Pegfilgrastim)……………………………………………………………………………… ..

4.8.1.6 Biosimilars in Development for Rituxan (Rituximab)……………………………………………………………………………………. ..

4.9….. Development of MAbs…………………………………………………………………………………………………………………………………….. ..

4.9.1.. Number of Biosimilar MAbs in the Pipeline…………………………………………………………………………………………………… ..

4.9.2.. Development of Biosimilar MAbs in South Korea…………………………………………………………………………………………. ..

4.9.3.. Indian Players in Biosimilar Industry…………………………………………………………………………………………………………….. ..

4.9.3.1 Indian Biosimilar Pipeline……………………………………………………………………………………………………………………………… ..

4.10… Biosimilar Map in Table Format……………………………………………………………………………………………………………………… ..

5.0….. Biobetters: An Overview…………………………………………………………………………………………………………………………………. ..

5.1….. Regulatory Considerations for Biobetters……………………………………………………………………………………………………….. ..

5.2….. General Differences between a Biosimilar and a Biobetter…………………………………………………………………………….. ..

5.3….. Biobetters in Development………………………………………………………………………………………………………………………………. ..

5.3.1.. Development of Biobetters by Stage………………………………………………………………………………………………………………. ..

5.4….. Biobetter Development in South Korea…………………………………………………………………………………………………………… ..

6.0….. The Approved Biosimilars: An Overview……………………………………………………………………………………………………….. ..

6.1….. Authorized Biosimilars in Europe…………………………………………………………………………………………………………………… ..

6.1.1.. Approved Biosimilars in Europe by Class……………………………………………………………………………………………………… ..

6.2….. An Overview of Nineteen Biosimilars Approved in Europe……………………………………………………………………………. ..

6.2.1.. Abasaglar………………………………………………………………………………………………………………………………………………………… ..

6.2.2.. Abseamed……………………………………………………………………………………………………………………………………………………….. ..

6.2.3.. Accofil……………………………………………………………………………………………………………………………………………………………. ..

6.2.4.. Bemfola………………………………………………………………………………………………………………………………………………………….. ..

6.2.5.. Binocrit…………………………………………………………………………………………………………………………………………………………… ..

6.2.6.. Biograstim………………………………………………………………………………………………………………………………………………………. ..

6.2.7.. Epoetin Alfa Hexal…………………………………………………………………………………………………………………………………………. ..

6.2.8.. Filgrastim Hexal…………………………………………………………………………………………………………………………………………….. ..

6.2.9.. Grastofil………………………………………………………………………………………………………………………………………………………….. ..

6.2.10 Inflectra………………………………………………………………………………………………………………………………………………………….. ..

6.2.11 Nivestim…………………………………………………………………………………………………………………………………………………………. ..

6.2.12 Omnitrope………………………………………………………………………………………………………………………………………………………. ..

6.2.13 Ovaleap…………………………………………………………………………………………………………………………………………………………… ..

6.2.14 Ratiograstim……………………………………………………………………………………………………………………………………………………. ..

6.2.15 Remsima…………………………………………………………………………………………………………………………………………………………. ..

6.2.16 Retacrit…………………………………………………………………………………………………………………………………………………………… ..

6.2.17 Silapo……………………………………………………………………………………………………………………………………………………………… ..

6.2.18 Tevagrastim……………………………………………………………………………………………………………………………………………………. ..

6.2.19 Zarzio……………………………………………………………………………………………………………………………………………………………… ..

6.3….. Biosimilar Penetration in Europe…………………………………………………………………………………………………………………….. ..

6.3.1.. Biosimilar EPO Utilization in Europe…………………………………………………………………………………………………………….. ..

6.3.1.1 European Market Leaders for Biosimilar EPO………………………………………………………………………………………………. ..

6.3.2.. Biosimilar G-CSF in Europe…………………………………………………………………………………………………………………………… ..

6.3.2.1 Penetration of G-CSF Biosimilars in Europe…………………………………………………………………………………………………. ..

6.3.2.2 The Three Major Biosimilar G-CSF Players in Europe………………………………………………………………………………….. ..

6.4….. Price Differentials between  Branded Neupogen, Eprex, Genotropin and their Biosimilar Counterparts in Europe            ..

6.5….. Biosimilars in Germany…………………………………………………………………………………………………………………………………… ..

6.6….. Biosimilars Approved and Marketed in Netherlands………………………………………………………………………………………. ..

6.7….. Biosimilars Available in U.K. for Myeloma……………………………………………………………………………………………………. ..

6.8….. Biosimilars Approved and Marketed in South Korea……………………………………………………………………………………… ..

6.9….. Biosimilars Approved and Marketed in Japan…………………………………………………………………………………………………. ..

6.10… Biosimilar MAbs in Latin America…………………………………………………………………………………………………………………. ..

6.11… Biosimilars Approved in India………………………………………………………………………………………………………………………… ..

7.0….. The Impact of Biosimilars on Originators: An overview………………………………………………………………………………… ..

7.1….. Biosimilar Impact on Epogen………………………………………………………………………………………………………………………….. ..

7.1.1.. Available Biosimilars for Epogen…………………………………………………………………………………………………………………… ..

7.1.2.. Cost of Epogen Treatment……………………………………………………………………………………………………………………………… ..

7.2….. Impact of Biosimilars on Humira…………………………………………………………………………………………………………………….. ..

7.2.1.. Biosimilars of Humira……………………………………………………………………………………………………………………………………. ..

7.3….. Impact of Biosimilars on Remicade………………………………………………………………………………………………………………… ..

7.3.1.. Biosimilars for Remicade……………………………………………………………………………………………………………………………….. ..

7.4….. Impact of Biosimilars on Neupogen………………………………………………………………………………………………………………… ..

7.4.1.. Biosimilars of Neupogen………………………………………………………………………………………………………………………………… ..

7.5….. The Impact of Biosimilars on Neulasta……………………………………………………………………………………………………………. ..

7.5.1.. Biosimilars for Neulasta…………………………………………………………………………………………………………………………………. ..

7.6….. Impact of Biosimilars on Enbrel……………………………………………………………………………………………………………………… ..

7.6.1.. Biosimilars to Enbrel……………………………………………………………………………………………………………………………………… ..

7.7….. Impact of Biosimilars on Rituxan……………………………………………………………………………………………………………………. ..

7.7.1.. Biosimilars of Rituxan……………………………………………………………………………………………………………………………………. ..

7.8….. Impact of Biosimilars on Herceptin…………………………………………………………………………………………………………………. ..

7.8.1.. Biosimilars of Herceptin…………………………………………………………………………………………………………………………………. ..

7.9….. Impact of Biosimilars on Avastin……………………………………………………………………………………………………………………. ..

7.9.1.. Biosimilars of Avastin……………………………………………………………………………………………………………………………………. ..

7.10… Impact of Biosimilars on Lantus……………………………………………………………………………………………………………………… ..

7.10.1 Biosimilars of Lantus……………………………………………………………………………………………………………………………………… ..

8.0….. Top Ten Biologics on the Focus of Biosimilar Developers…………………………………………………………………………….. ..

8.1….. Aranesp (Darbepoietin alfa)…………………………………………………………………………………………………………………………….. ..

8.2….. Enbrel………………………………………………………………………………………………………………………………………………………………. ..

8.3….. Epogen/Procrit/Eprex/Erypo……………………………………………………………………………………………………………………………. ..

8.4….. Genotropin………………………………………………………………………………………………………………………………………………………. ..

8.5….. Herceptin…………………………………………………………………………………………………………………………………………………………. ..

8.6….. Humira…………………………………………………………………………………………………………………………………………………………….. ..

8.7….. Neulasta…………………………………………………………………………………………………………………………………………………………… ..

8.8….. Neupogen………………………………………………………………………………………………………………………………………………………… ..

8.9….. Remicade…………………………………………………………………………………………………………………………………………………………. ..

8.10… Rituxan…………………………………………………………………………………………………………………………………………………………….. ..

9.0….. Five Major Classes of Originator Biologics and their Market Performance……………………………………………………. ..

9.1….. Monoclonal Antibodies (MAbs)……………………………………………………………………………………………………………………… ..

9.1.1.. Biosimilar MAbs in Pipeline………………………………………………………………………………………………………………………….. ..

9.2….. Tumor-Necrosis-Factor Alpha (TNF-alpha)……………………………………………………………………………………………………. ..

9.2.1.. Biosimilar TNF-alpha Blockers……………………………………………………………………………………………………………………… ..

9.2.2.. Biosimilar TNF-alpha Blockers in Development……………………………………………………………………………………………. ..

9.3….. Erythropoietin (EPO)………………………………………………………………………………………………………………………………………. ..

9.3.1.. Biosimilars of EPO…………………………………………………………………………………………………………………………………………. ..

9.4….. Insulins…………………………………………………………………………………………………………………………………………………………….. ..

9.4.1.. FDA-Approved Human Insulins…………………………………………………………………………………………………………………….. ..

9.4.2.. Biosimilar Insulins………………………………………………………………………………………………………………………………………….. ..

9.5….. Granulocyte-Colony Stimulating Factor (G-CSF)…………………………………………………………………………………………… ..

9.5.1.. Neupogen’s Biosimilars…………………………………………………………………………………………………………………………………. ..

10.0… The Landscape of the Originators of Biosimilars……………………………………………………………………………………………. ..

10.1… Domination of Biologics among the Top Ten Drugs in the U.S……………………………………………………………………… ..

10.1.1 Medicare Spending on Biologics……………………………………………………………………………………………………………………. ..

10.1.2 U.S. Patent Expiry Dates for Best-Selling Biologics……………………………………………………………………………………… ..

10.2… Top Eight Biologics in European Market………………………………………………………………………………………………………… ..

10.2.1 Domination of Biologics in Germany…………………………………………………………………………………………………………….. ..

10.3… Distribution of Biopharmaceutical Companies……………………………………………………………………………………………….. ..

10.4… The Most Expensive Drugs……………………………………………………………………………………………………………………………… ..

10.4.1 The Average Cost of Treatment with Biologic Drugs…………………………………………………………………………………….. ..

10.5… Top 15 Biopharma Companies by Revenue…………………………………………………………………………………………………….. ..

10.6… Projected Global Market for Top-Selling Biologics………………………………………………………………………………………… ..

10.7… Projected Sales of Top-Selling Biologics in the U.S. Market………………………………………………………………………….. ..

10.8… Comparison of Treatment Costs of Biologics and Non-Biologics…………………………………………………………………… ..

11.0… A Brief Analysis of Market for Biologics……………………………………………………………………………………………………….. ..

11.1… Global Market for Biologics: Sales and Growth Rate for the Past Six Years………………………………………………….. ..

11.2… Projected Market for Biologics by Geography………………………………………………………………………………………………… ..

11.3… Top Ten Biopharmaceutical Companies………………………………………………………………………………………………………….. ..

11.4… Top-Selling Biologics by Class……………………………………………………………………………………………………………………….. ..

11.5… Five Biologics Least Affected by Biosimilars…………………………………………………………………………………………………. ..

11.5.1 Sustained Growth for Humira…………………………………………………………………………………………………………………………. ..

11.5.2 Lantus Facing Imminent Competition……………………………………………………………………………………………………………. ..

11.5.3 Higher Growth for Xarelto……………………………………………………………………………………………………………………………… ..

11.5.4 Prenvar13: World’s leading Vaccine……………………………………………………………………………………………………………… ..

11.5.5 Eyelea: Surpassing the Predecessors………………………………………………………………………………………………………………. ..

11.6… Five Biologics Showing Marginal declines in Sales……………………………………………………………………………………….. ..

11.6.1 The Uncertain Revenue Base for Enbrel in the International Market…………………………………………………………….. ..

11.6.2 A Small Decline in Sales for Avastin……………………………………………………………………………………………………………… ..

11.6.3 Difficult Patient Access to Rituxan………………………………………………………………………………………………………………… ..

11.6.4 The Lining up of Biosimilars against Herceptin…………………………………………………………………………………………….. ..

12.0… Market for Biosimilars: An Overview…………………………………………………………………………………………………………….. ..

12.1… Past Seven Years of Market Performance by Biosimilars……………………………………………………………………………….. ..

12.2… Loss of Patent Protection for Biologics: The Major Driver of Biosimilars’ Market……………………………………….. ..

12.3… Relatively Small Size of Biosimilars’ Market Compared to Biologics’………………………………………………………….. ..

12.4… Favorable Signs for Increased Uptake of Biosimilars……………………………………………………………………………………… ..

12.5… Recent Events in Biosimilars’ Market…………………………………………………………………………………………………………….. ..

12.6… Future of Biosimilars……………………………………………………………………………………………………………………………………….. ..

12.7… Market for Biosimilars by Geography…………………………………………………………………………………………………………….. ..

12.8… Global Market for Biosimilars by Drug Class…………………………………………………………………………………………………. ..

12.9… Biosimilar Market Leaders………………………………………………………………………………………………………………………………. ..

12.10. Distribution of Biosimilar Companies by Geography……………………………………………………………………………………… ..

12.10.1 The Largest Markets for Biosimilars in Europe…………………………………………………………………………………………….. ..

12.10.1.1 Biosimilars’ Market in Germany………………………………………………………………………………………………………………… ..

12.10.1.2 Norway’s Efforts to Achieve Larger Biosimilar Uptake……………………………………………………………………………. ..

12.11. The Market Potential for Biosimilars in the U.S……………………………………………………………………………………………… ..

12.11.1 Optimistic Predictions for the Growth of Biosimilars’ Market in the U.S…………………………………………………….. ..

12.11.2 Viability of Biosimilars in the U.S………………………………………………………………………………………………………………… ..

12.11.3 Projected Savings with Biosimilars in the U.S……………………………………………………………………………………………… ..

12.11.4 Multiple Challenges for Biosimilars’ Entry into the U.S. Market…………………………………………………………………. ..

12.11.5 Break-Even Analysis for Biosimilars in the U.S…………………………………………………………………………………………… ..

12.11.6  Biosimilars About to Enter the U.S. Market………………………………………………………………………………………………… ..

12.12. SWOT Analysis………………………………………………………………………………………………………………………………………………. ..

12.12.1 Strengths……………………………………………………………………………………………………………………………………………………….. ..

12.12.2 Weaknesses…………………………………………………………………………………………………………………………………………………… ..

12.12.3 Opportunities…………………………………………………………………………………………………………………………………………………. ..

12.12.4 Threats…………………………………………………………………………………………………………………………………………………………… ..

12.12.5 Market Drivers………………………………………………………………………………………………………………………………………………. ..

12.12.6 Barriers………………………………………………………………………………………………………………………………………………………….. ..

13.0… Selected Company Profiles……………………………………………………………………………………………………………………………… ..

13.1… 3SBio Inc…………………………………………………………………………………………………………………………………………………………. ..

13.1.1 Biosimilars from 3SBio………………………………………………………………………………………………………………………………….. ..

13.2… Abzena…………………………………………………………………………………………………………………………………………………………….. ..

13.3… Actavis plc……………………………………………………………………………………………………………………………………………………….. ..

13.3.1 Actavis’ Biosimilars……………………………………………………………………………………………………………………………………….. ..

13.4… AET BioTech…………………………………………………………………………………………………………………………………………………… ..

13.4.1 Distribution Agreement for Adalimumab………………………………………………………………………………………………………. ..

13.4.2 Codevelopment of Adalimumab…………………………………………………………………………………………………………………….. ..

13.5… Alvogen Inc…………………………………………………………………………………………………………………………………………………….. ..

13.6… Amega Biotech………………………………………………………………………………………………………………………………………………… ..

13.7… Amgen Inc……………………………………………………………………………………………………………………………………………………….. ..

13.8… Anhui Anke Biotechnology (Group) Co., Ltd…………………………………………………………………………………………………. ..

13.9… Apotex Inc……………………………………………………………………………………………………………………………………………………….. ..

13.9.1 Biosimilars from Apotex………………………………………………………………………………………………………………………………… ..

13.10. Avesthagen Ltd……………………………………………………………………………………………………………………………………………….. ..

13.10.1 Agreement with Elpen…………………………………………………………………………………………………………………………………… ..

13.10.2 Alliance with Kemwell Biopharma……………………………………………………………………………………………………………….. ..

13.11. Baxter International Inc…………………………………………………………………………………………………………………………………… ..

13.11.1 Collaboration with Coherus…………………………………………………………………………………………………………………………… ..

13.11.2 Collaboration with Momenta…………………………………………………………………………………………………………………………. ..

13.12. Beijing Four Rings Biopharmaceutical Co., Ltd……………………………………………………………………………………………… ..

13.13. Bharat Biotech International Ltd……………………………………………………………………………………………………………………… ..

13.13.1 Regen-D 150…………………………………………………………………………………………………………………………………………………. ..

13.13.2 Regen-D 60……………………………………………………………………………………………………………………………………………………. ..

13.14. Biocon Ltd………………………………………………………………………………………………………………………………………………………. ..

13.14.1 Human Insulin……………………………………………………………………………………………………………………………………………….. ..

13.14.2 Insulin Glargine…………………………………………………………………………………………………………………………………………….. ..

13.14.3 Insulin Lispro………………………………………………………………………………………………………………………………………………… ..

13.14.4 Insulin Aspart………………………………………………………………………………………………………………………………………………… ..

13.14.5 Erythropoietin (EPO)…………………………………………………………………………………………………………………………………….. ..

13.14.6 Filgrastim (GCSF)…………………………………………………………………………………………………………………………………………. ..

13.14.7 Streptokinase…………………………………………………………………………………………………………………………………………………. ..

13.14.8 Monoclonal Antibodies (MAbs)……………………………………………………………………………………………………………………. ..

13.14. 9 Contract Manufacturing……………………………………………………………………………………………………………………………….. ..

13.14.10 Research Services……………………………………………………………………………………………………………………………………….. ..

13.15. Biogen Inc……………………………………………………………………………………………………………………………………………………….. ..

13.15.1Joint Venture with Samsung…………………………………………………………………………………………………………………………… ..

13.16. Bionovis SA…………………………………………………………………………………………………………………………………………………….. ..

13.16.1 Bionovis’ Product Pipeline……………………………………………………………………………………………………………………………. ..

13.17. Biopartners GmbH…………………………………………………………………………………………………………………………………………… ..

13.17.1 Somatropin……………………………………………………………………………………………………………………………………………………. ..

13.18. Biosidus S.A……………………………………………………………………………………………………………………………………………………. ..

13.19. Bioton Spólka Akcyjna……………………………………………………………………………………………………………………………………. ..

13.19.1 Agreement with Medipolis……………………………………………………………………………………………………………………………. ..

13.19.2 Agreement with Actavis………………………………………………………………………………………………………………………………… ..

13.20. Bioviz Technologies Pvt., Ltd…………………………………………………………………………………………………………………………. ..

13.21. BioXpress Therapeutics SA…………………………………………………………………………………………………………………………….. ..

13.21.1 Future Programs……………………………………………………………………………………………………………………………………………. ..

13.22. Biotechnol AS…………………………………………………………………………………………………………………………………………………. ..

13.22. Tb535……………………………………………………………………………………………………………………………………………………………… ..

13.22.2 Tb434…………………………………………………………………………………………………………………………………………………………….. ..

13.23. Boehringer Ingelheim GmbH………………………………………………………………………………………………………………………….. ..

13.23.1 Boehringer’s Biosimilar Efforts…………………………………………………………………………………………………………………….. ..

13.24. Bolder BioTechnology Inc………………………………………………………………………………………………………………………………. ..

13.25. Cadilla Pharmaceuticals Ltd……………………………………………………………………………………………………………………………. ..

13.25.1 Exemptia……………………………………………………………………………………………………………………………………………………….. ..

13.26. Celltrion Inc…………………………………………………………………………………………………………………………………………………….. ..

13.26.1 Remsima……………………………………………………………………………………………………………………………………………………….. ..

13.26.2 Product Candidates……………………………………………………………………………………………………………………………………….. ..

13.26.2.1 CT-P6…………………………………………………………………………………………………………………………………………………………. ..

13.26.2.2 CT-P10……………………………………………………………………………………………………………………………………………………….. ..

13.27. Cerbios-Pharma S.A………………………………………………………………………………………………………………………………………… ..

13.27.1 Biological Services……………………………………………………………………………………………………………………………………….. ..

13.27.2 Biotechnology Services…………………………………………………………………………………………………………………………………. ..

13.27.3 Recombinant Urokinase………………………………………………………………………………………………………………………………… ..

13.27. Recombinant G-CSF………………………………………………………………………………………………………………………………………. ..

13.28. Cipla Ltd………………………………………………………………………………………………………………………………………………………….. ..

13.28.1 Etacept…………………………………………………………………………………………………………………………………………………………… ..

13.28.2 Actorise…………………………………………………………………………………………………………………………………………………………. ..

13.29. CJSC Biocad……………………………………………………………………………………………………………………………………………………. ..

13.29. AcellBia………………………………………………………………………………………………………………………………………………………….. ..

13.30. Ckd Bio Corp…………………………………………………………………………………………………………………………………………………… ..

13.30.1 Phase I Study of Darbepoietin alfa Biosimilar………………………………………………………………………………………………. ..

13.31. Claris Lifesciences Ltd……………………………………………………………………………………………………………………………………. ..

13.31.1 Fegrast…………………………………………………………………………………………………………………………………………………………… ..

13.32. Coherus Biosciences Inc………………………………………………………………………………………………………………………………….. ..

13.32.1 The Pipeline…………………………………………………………………………………………………………………………………………………… ..

13.33. CT Arzneimittel GmbH…………………………………………………………………………………………………………………………………… ..

13.33.1 Biograstim…………………………………………………………………………………………………………………………………………………….. ..

13.34. Dawoong Pharmaceutical Co. Ltd…………………………………………………………………………………………………………………… ..

13.35. Dong-A Socio Holdings Co., Ltd…………………………………………………………………………………………………………………….. ..

13.36. Dr. Reddy’s Laboratories Ltd………………………………………………………………………………………………………………………….. ..

13.36.1 Grafeel…………………………………………………………………………………………………………………………………………………………… ..

13.36.2 Reditux………………………………………………………………………………………………………………………………………………………….. ..

13.36.3 Cresp……………………………………………………………………………………………………………………………………………………………… ..

13.36.4 Peg-Grafeel……………………………………………………………………………………………………………………………………………………. ..

13.37. Eli Lilly & Co………………………………………………………………………………………………………………………………………………….. ..

13.37.1 Abasria………………………………………………………………………………………………………………………………………………………….. ..

13.37.2 Basalgar…………………………………………………………………………………………………………………………………………………………. ..

13.38. Emcure Pharmaceuticals Ltd…………………………………………………………………………………………………………………………… ..

13.38.1Biosimilar for Herceptin…………………………………………………………………………………………………………………………………. ..

13.39. Epirus Biopharmaceuticals Inc………………………………………………………………………………………………………………………… ..

13.39.1 Epirus’ Programs…………………………………………………………………………………………………………………………………………… ..

13.40. Finox AG…………………………………………………………………………………………………………………………………………………………. ..

13.40.1 Bemfola r-FSH………………………………………………………………………………………………………………………………………………. ..

13.41. Fujifilm Diosynth Biotechnologies………………………………………………………………………………………………………………….. ..

13.41.1 Joint Venture with Kyowa…………………………………………………………………………………………………………………………….. ..

13.42. Gan & Lee Pharmaceuticals Ltd……………………………………………………………………………………………………………………… ..

13.43. GeneScience Pharmaceuticals Co., Ltd…………………………………………………………………………………………………………… ..

13.44. Genexine Co. Ltd…………………………………………………………………………………………………………………………………………….. ..

13.45. Gennova Biopharmaceuticals Ltd……………………………………………………………………………………………………………………. ..

13.45.1 Gennova’s Biosimilar……………………………………………………………………………………………………………………………………. ..

13.46. Genor BioPharma Co., Ltd………………………………………………………………………………………………………………………………. ..

13.46.1 Genor’s Pipeline……………………………………………………………………………………………………………………………………………. ..

13.47. Glenmark Pharmaceuticals Ltd……………………………………………………………………………………………………………………….. ..

13.47.1GBR 830………………………………………………………………………………………………………………………………………………………… ..

13.47.2GBR 900………………………………………………………………………………………………………………………………………………………… ..

13.47.3 GBR 500……………………………………………………………………………………………………………………………………………………….. ..

13.48. Glycotope GmbH…………………………………………………………………………………………………………………………………………….. ..

13.48.1 Glycotope’s Pipeline……………………………………………………………………………………………………………………………………… ..

13.49. Green Cross Corp……………………………………………………………………………………………………………………………………………. ..

13.50. HanAll BioPharma Co., Ltd…………………………………………………………………………………………………………………………….. ..

13.51. Hanwha Chemical Corp…………………………………………………………………………………………………………………………………… ..

13.51.1 HD203…………………………………………………………………………………………………………………………………………………………… ..

13.52. Harvest Moon Pharmaceuticals USA Inc………………………………………………………………………………………………………… ..

13.52.1 Stable Cell Lines for Biosimilar Development……………………………………………………………………………………………… ..

13.53. Hetero Drugs Ltd…………………………………………………………………………………………………………………………………………….. ..

13.53.1 Darbepoetin alfa……………………………………………………………………………………………………………………………………………. ..

13.54. Hexal AG…………………………………………………………………………………………………………………………………………………………. ..

13.54.1 EPO-alfa Hexal……………………………………………………………………………………………………………………………………………… ..

13.54.2 Filgrastim Hexal……………………………………………………………………………………………………………………………………………. ..

13.55. Hospira Inc………………………………………………………………………………………………………………………………………………………. ..

13.55.1 Retacrit………………………………………………………………………………………………………………………………………………………….. ..

13.55.2 Nivestim………………………………………………………………………………………………………………………………………………………… ..

13.55.3 Inflectra…………………………………………………………………………………………………………………………………………………………. ..

13.56. Innovent Biologics Inc…………………………………………………………………………………………………………………………………….. ..

13.56.1 IB1301…………………………………………………………………………………………………………………………………………………………… ..

13.56.2 IB1302…………………………………………………………………………………………………………………………………………………………… ..

13.56.3 IB1303…………………………………………………………………………………………………………………………………………………………… ..

13.56.4 IB1305…………………………………………………………………………………………………………………………………………………………… ..

13.56.5 IB1306…………………………………………………………………………………………………………………………………………………………… ..

13.56.6IB1308……………………………………………………………………………………………………………………………………………………………. ..

13.57. Intas Pharmaceuticals Ltd……………………………………………………………………………………………………………………………….. ..

13.58. ISU Abxis Co. Ltd…………………………………………………………………………………………………………………………………………… ..

13.58.1 Clotinab…………………………………………………………………………………………………………………………………………………………. ..

13.58.2 ISU101………………………………………………………………………………………………………………………………………………………….. ..

13.58.3 ISU302 & 303……………………………………………………………………………………………………………………………………………….. ..

13.58.4 ISU201………………………………………………………………………………………………………………………………………………………….. ..

13.59. Kyowa Hakko Kirin Pharma Inc……………………………………………………………………………………………………………………… ..

13.60. LG Life Sciences Co., Ltd……………………………………………………………………………………………………………………………….. ..

13.60.1 Adalimumab Biosimilar………………………………………………………………………………………………………………………………… ..

13.61. Lupin Ltd…………………………………………………………………………………………………………………………………………………………. ..

13.61.1 Lupin’s Biosimilar………………………………………………………………………………………………………………………………………… ..

13.62. Mabion SA………………………………………………………………………………………………………………………………………………………. ..

13.62.1 Phase III for Rituximab Biosimilar……………………………………………………………………………………………………………….. ..

13.63. mAbxience S.A……………………………………………………………………………………………………………………………………………….. ..

13.63.1 mAbxience’s Biosimilars………………………………………………………………………………………………………………………………. ..

13.64. MacroGenics Inc……………………………………………………………………………………………………………………………………………… ..

13.64.1Collaboration with Janssen…………………………………………………………………………………………………………………………….. ..

13.64.2 Collaboration with Gilead……………………………………………………………………………………………………………………………… ..

13.64.3 Collaboration with Boehringer Ingelheim…………………………………………………………………………………………………….. ..

13.64.4 Collaboration with Green Cross……………………………………………………………………………………………………………………. ..

13.64.5 Collaboration with Takeda…………………………………………………………………………………………………………………………….. ..

13.64.6 Collaboration with Pfizer………………………………………………………………………………………………………………………………. ..

13.64.7 MacroGenic’s Pipeline………………………………………………………………………………………………………………………………….. ..

13.64.7.1 Margetuximab…………………………………………………………………………………………………………………………………………….. ..

13.64.7.2 MGA271…………………………………………………………………………………………………………………………………………………….. ..

13.64.7.3MGD006……………………………………………………………………………………………………………………………………………………… ..

13.64.7.4 MGD007…………………………………………………………………………………………………………………………………………………….. ..

13.64.7.5 MGD001…………………………………………………………………………………………………………………………………………………….. ..

13.64.7.6 MGD010…………………………………………………………………………………………………………………………………………………….. ..

13.64.7.7 Teplizumab…………………………………………………………………………………………………………………………………………………. ..

13.65. Medice Arzneimittel Putter GmbH & Co. KG………………………………………………………………………………………………… ..

13.65.1 Abseamed……………………………………………………………………………………………………………………………………………………… ..

13.66. Merck Serono………………………………………………………………………………………………………………………………………………….. ..

13.66.1 Serono’s Biosimilar Programs………………………………………………………………………………………………………………………. ..

13.67. Merck & Co., Inc…………………………………………………………………………………………………………………………………………….. ..

13.67.1 Biosimilar Development and Commercialization Agreement with Samsung Bioepis………………………………….. ..

13.68. MJ Biopharm Pvt. Ltd……………………………………………………………………………………………………………………………………… ..

13.69. Mochida Pharmaceutical Co. Ltd……………………………………………………………………………………………………………………. ..

13.69.1 LBEC0101 Trial……………………………………………………………………………………………………………………………………………. ..

13.69.2 Collaboration wirh LG Life Sciences……………………………………………………………………………………………………………. ..

13.70. Momenta Pharmaceuticals Inc………………………………………………………………………………………………………………………… ..

13.70.1 Momenta’s Biosimilars Program…………………………………………………………………………………………………………………… ..

13.71. Mycenax Biotech Inc………………………………………………………………………………………………………………………………………. ..

13.71.1 TuNEX………………………………………………………………………………………………………………………………………………………….. ..

13.72. Mylan NV………………………………………………………………………………………………………………………………………………………… ..

13.72.1 First Trastuzumab Biosimilar………………………………………………………………………………………………………………………… ..

13.72.2 Two U.S. Phase III Clinical Trials for Insulin Glargine………………………………………………………………………………… ..

13.72.3 Partnership with Biocon………………………………………………………………………………………………………………………………… ..

13.73. Nippon Kayaku Co. Ltd…………………………………………………………………………………………………………………………………… ..

13.73.1 Nippon’s Biosimilars…………………………………………………………………………………………………………………………………….. ..

13.74. Oncobiologics Inc……………………………………………………………………………………………………………………………………………. ..

13.75. Pfizer Inc…………………………………………………………………………………………………………………………………………………………. ..

13.76. Pharma Praxis………………………………………………………………………………………………………………………………………………….. ..

13.77. PlantForm Corporation……………………………………………………………………………………………………………………………………. ..

13.78. Polpharma SA………………………………………………………………………………………………………………………………………………….. ..

13.78.1 Polpharma’s Collaboration for Biosimilars…………………………………………………………………………………………………… ..

13.79. Probiomed S.A. de C.V…………………………………………………………………………………………………………………………………… ..

13.80. Protalix BioTherapeutics Inc…………………………………………………………………………………………………………………………… ..

13.80.1 Biobetters from Protalix………………………………………………………………………………………………………………………………… ..

13.80.1.1 PRX-102…………………………………………………………………………………………………………………………………………………….. ..

13.80.1.2 Oral Anti-TNF……………………………………………………………………………………………………………………………………………. ..

13.80.1.3 AIR DNase…………………………………………………………………………………………………………………………………………………. ..

13.80.1.4 Oral GCD……………………………………………………………………………………………………………………………………………………. ..

13.81. Ranbaxy Laboratories Ltd. (Sun Pharmaceutical Industries Ltd.)…………………………………………………………………… ..

13.81.1 Infimab………………………………………………………………………………………………………………………………………………………….. ..

13.82. Ratiopharm GmbH………………………………………………………………………………………………………………………………………….. ..

13.82.1 Ratiograstim………………………………………………………………………………………………………………………………………………….. ..

13.83. Reliance Life Sciences Pvt. Ltd………………………………………………………………………………………………………………………. ..

13.83.1 ReliFeron………………………………………………………………………………………………………………………………………………………. ..

13.83.2 ReliPoietin…………………………………………………………………………………………………………………………………………………….. ..

13.83.3 ReliGrast……………………………………………………………………………………………………………………………………………………….. ..

13.83.4 MIRel…………………………………………………………………………………………………………………………………………………………….. ..

13.83.5 FostiRel…………………………………………………………………………………………………………………………………………………………. ..

13.83.6 ReliBeta…………………………………………………………………………………………………………………………………………………………. ..

13.83.7 ChorioRel………………………………………………………………………………………………………………………………………………………. ..

13.83.8 AbcixiRel………………………………………………………………………………………………………………………………………………………. ..

13.84. Samsung Bioepis Co., Ltd……………………………………………………………………………………………………………………………….. ..

13.85. Sandoz Inc……………………………………………………………………………………………………………………………………………………….. ..

13.85.1 Sandoz’s Biosimilars…………………………………………………………………………………………………………………………………….. ..

13.85.2 Sandoz’s Biosimilar Clinical Trials………………………………………………………………………………………………………………. ..

13.86. Shanghai CP Guojian Pharmaceutical Co., Ltd……………………………………………………………………………………………….. ..

13.87. Shantha Biotechnics Ltd………………………………………………………………………………………………………………………………….. ..

13.87.1 Shanpoietin……………………………………………………………………………………………………………………………………………………. ..

13.89. Stada Arzneimittel AG…………………………………………………………………………………………………………………………………….. ..

13.89.1 Biosimilars from Stada………………………………………………………………………………………………………………………………….. ..

13.90. Synthon BV……………………………………………………………………………………………………………………………………………………… ..

13.90.1 SYD985…………………………………………………………………………………………………………………………………………………………. ..

13.90.2 Antibody Discovery Agreement……………………………………………………………………………………………………………………. ..

13.90.3 Global License Agreement for Biosimilar Trastuzumab……………………………………………………………………………….. ..

13.91. Teva Pharmaceutical Industries Ltd………………………………………………………………………………………………………………… ..

13.91.1 TevaGrastim………………………………………………………………………………………………………………………………………………….. ..

13.91.2 Ovaleap…………………………………………………………………………………………………………………………………………………………. ..

13.92. USV Ltd………………………………………………………………………………………………………………………………………………………….. ..

13.92.1 PEG-Filgrastim……………………………………………………………………………………………………………………………………………… ..

13.92.2 Teriparatide Injection……………………………………………………………………………………………………………………………………. ..

13.92.3 Somatropin……………………………………………………………………………………………………………………………………………………. ..

13.92.4 Filgrastim Injection……………………………………………………………………………………………………………………………………….. ..

13.93. Wockhardt Ltd………………………………………………………………………………………………………………………………………………… ..

13.93.1 Glaritus………………………………………………………………………………………………………………………………………………………….. ..

13.93.2 Wepox…………………………………………………………………………………………………………………………………………………………… ..

13.94. Xencor Inc……………………………………………………………………………………………………………………………………………………….. ..

13.95. Xiamen Amoytop Biotech Co., Ltd…………………………………………………………………………………………………………………. ..

13.95.1 Filgrastim (rHuG-CSF)…………………………………………………………………………………………………………………………………. ..

13.95.2 Oprelvekin (rHuIL-11)………………………………………………………………………………………………………………………………….. ..

13.95.3 Molgramostim (rHuGM-CSF)………………………………………………………………………………………………………………………. ..

14.0… Biosimilar Market Participants and their Focused Products……………………………………………………………………………. ..

 

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