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Biosimilars in Oncology

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  • 154 Pages
  • August 2018
  • Region: Global
  • GlobalData
  • ID: 4655639
Biosimilars in Oncology


Recent trends in drug development have seen the price of new medicines continually increase, and there is a need for cheaper medicines to achieve global sustainable healthcare. Biologic drugs are some of the most expensive medicines to develop, as they are large complex molecules. Biosimilars are highly similar to approved biologic drugs, with no clinically relevant differences, and aim to achieve the same clinical results at a lower price than their originator molecules. This is a key way in which the cost-savings required to promote sustainability can be achieved.

In oncology, biosimilar versions of six biologic drugs are now available. The EMA has pioneered regulatory acceptance of biosimilars, and has approved many more biosimilars than the FDA. Beyond the major markets of the US and 5EU (France, Germany, Italy, Spain and UK), two emerging markets are important in the oncology biosimilars landscape: India, with the most approved biosimilars globally, and South Korea, home to major biosimilar developer Celltrion.

This report provides an assessment of the current oncology biosimilars landscape in the 9MM (US, 5EU, Japan, India and South Korea), including market potential, current and expected use of biosimilars, clinical and commercial concepts, regulatory pathways, important indications, and an overview of leading and emerging developers.


The report combines primary research from oncology experts and a high prescribing physicians’ survey with in-house analyst expertise to provide an assessment of the marketplace. Components of the slide deck include primary and secondary research:
  • Quotes from 11 US-, 5EU-, Japan-, and India-based experts, including Key Opinion Leaders (KOLs) and payers

  • Quantitative survey information from 107 US-, 5EU-, India-, South Korea-based high-prescribing physicians

  • Summary of key clinical and commercial concepts for biosimilars

  • Overview of biosimilar regulatory pathways across key markets

  • Analysis of potential of each key biosimilars market

  • Outline of important indications for oncology biosimilars

  • Review of key biosimilar developers and their portfolios

  • Insight from the Author’s specialist oncology analysts.

Reasons to buy
  • Develop and design your in-licensing and out-licensing strategies through a review of the oncology biosimilar landscape and its key players.

  • Organize your efforts by understanding the market potential and current regulatory outlook shaping the oncology biosimilars landscape in key markets.

  • Develop strategies by understanding expert and high prescriber perceptions of biosimilars, and drivers for current use patterns and expected changes in use.

Table of Contents

1. Preface
1.1 Related Reports
1.2 Upcoming Reports
1.3 Abbreviations
2. Executive Summary
3. Introduction
3.1 What Is a Biosimilar?
3.2 Timeline of Oncology Biosimilar Development by Country in the 7MM
3.3 Timeline of Oncology Biosimilar Approvals in India and South Korea
4. Biosimilars - Key Clinical and Commercial Concepts
4.1 Differences Between Generics and Biosimilars
4.2 Differences Between Biosimilarity and Interchangeability
4.3 Pricing Issues for Biosimilars
5. Biosimilar Regulatory Pathways Across Geographies
5.1 Biosimilar Development Overview
5.2 US Biosimilar Regulatory Pathway
5.3 EU Biosimilar Regulatory Pathway
5.4 Japan Biosimilar Regulatory Pathway
5.5 South Korea Biosimilar Regulatory Pathway
5.6 India Biosimilar Regulatory Pathway
6. Biosimilar Market Potential in the 9MM
6.1 US Biosimilar Market Potential
6.2 5EU Biosimilar Market Potential
6.3 Japan Biosimilar Market Potential
6.4 South Korea Biosimilar Market Potential
6.5 India Biosimilar Market Potential
7. Important Indications for Oncology Biosimilars
7.1 Biologic Use Across Oncology
7.2 HER2+ Breast Cancer
7.3 Colorectal Cancer
7.4 Hematological Cancers - NHL and CLL
7.5 Supportive Care in Oncology
8. Major Players and Emerging Players
8.1 Importance of Manufacturer Reputation
8.2 Sandoz as a Major Player
8.3 Celltrion as a Major Player
8.4 Amgen as a Major Player
8.5 Mylan and Biocon as Major Players
8.6 Pfizer and Boehringer Ingelheim as Emerging Players
9. Current Market Dynamics and Future Outlook: Results from a High-Prescriber Survey
9.1 Current Availability of Approved Biosimilars
9.2 Patterns of Use of Oncology Biosimilars
9.3 Substitution Rules by Country
9.4 Pricing Regulations for Biosimilars by Country
9.5 Desired Discounts for Oncology Biosimilars
9.6 Expected Changes in Prescription Patterns in the Next Five Years
9.7 Important Initiatives to Encourage Future Use of Biosimilars
10. Appendix
10.1 Primary Research
10.2 Sources
10.3 About the Authors
10.4 About
10.5 Contact
10.6 Disclaimer

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Accord Healthcare
  • Alkem Laboratories
  • Amgen
  • Apobiologix
  • Apotex
  • Archigen Biotech
  • Biocon
  • Bio-Thera
  • Boehringer Ingelheim
  • Cadila Healthcare
  • Celltrion
  • Centus Biotherapeutics
  • Cinfa Biotech
  • Cipla
  • Claris Lifesciences
  • Coherus BioSciences
  • CT Arzneimittel
  • Daewoong Pharmaceutical
  • Daiichi Sankyo
  • Dr. Reddy’s Laboratories
  • EirGenix
  • Emcure Pharmaceuticals
  • Fuji Pharma
  • Gedeon Richter
  • Glenmark Pharmaceuticals
  • Hetero Drugs
  • Hexal
  • Hospira
  • InnoVent
  • Intas Pharmaceuticals
  • Kissei Pharmaceutical
  • Kyowa Hakko Kirin
  • Lupin
  • Mabion
  • mAbxience
  • Medice Arzneimittel Putter
  • Meiji Seika Pharma
  • Merck & Co
  • Mochida Pharmaceutical
  • Mylan
  • Nippon Kayaku
  • Pfizer
  • Panacea Biotec
  • Prestige BioPharma
  • Prolong Pharmaceuticals
  • Ratiopharm
  • Reliance Life Sciences
  • Samsung Bioepis
  • Sandoz
  • Synthon Holdings
  • Tanvex BioPharma
  • Teva
  • Torrent Pharmaceuticals
  • USV
  • Wockhardt
  • Zenotech Laboratories