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Biosimilars in Oncology

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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 GlobalData'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 Content


Table of Contents

1. Preface 2

1.1 Related Reports 4

1.2 Upcoming Reports 5

1.3 Abbreviations 6

2. Executive Summary 8

3. Introduction 11

3.1 What Is a Biosimilar? 13

3.2 Timeline of Oncology Biosimilar Development by Country in the 7MM 15

3.3 Timeline of Oncology Biosimilar Approvals in India and South Korea 17

4. Biosimilars-Key Clinical and Commercial Concepts 18

4.1 Differences Between Generics and Biosimilars 20

4.2 Differences Between Biosimilarity and Interchangeability 21

4.3 Pricing Issues for Biosimilars 22

5. Biosimilar Regulatory Pathways Across Geographies 26

5.1 Biosimilar Development Overview 28

5.2 US Biosimilar Regulatory Pathway 34

5.3 EU Biosimilar Regulatory Pathway 36

5.4 Japan Biosimilar Regulatory Pathway 38

5.5 South Korea Biosimilar Regulatory Pathway 40

5.6 India Biosimilar Regulatory Pathway 42

6. Biosimilar Market Potential in the 9MM 44

6.1 US Biosimilar Market Potential 46

6.2 5EU Biosimilar Market Potential 48

6.3 Japan Biosimilar Market Potential 50

6.4 South Korea Biosimilar Market Potential 52

6.5 India Biosimilar Market Potential 54

7. Important Indications for Oncology Biosimilars 56

7.1 Biologic Use Across Oncology 58

7.2 HER2+ Breast Cancer 60

7.3 Colorectal Cancer 66

7.4 Hematological Cancers-NHL and CLL 73

7.5 Supportive Care in Oncology 80

8. Major Players and Emerging Players 87

8.1 Importance of Manufacturer Reputation 89

8.2 Sandoz as a Major Player 92

8.3 Celltrion as a Major Player 96

8.4 Amgen as a Major Player 99

8.5 Mylan and Biocon as Major Players 102

8.6 Pfizer and Boehringer Ingelheim as Emerging Players 107

9. Current Market Dynamics and Future Outlook: Results from a High-Prescriber Survey 112

9.1 Current Availability of Approved Biosimilars 114

9.2 Patterns of Use of Oncology Biosimilars 117

9.3 Substitution Rules by Country 126

9.4 Pricing Regulations for Biosimilars by Country 128

9.5 Desired Discounts for Oncology Biosimilars 131

9.6 Expected Changes in Prescription Patterns in the Next Five Years 134

9.7 Important Initiatives to Encourage Future Use of Biosimilars 137

10. Appendix 139

10.1 Primary Research 140

10.2 Sources 143

10.3 About the Authors 148

10.4 About GlobalData 151

10.5 Contact Us 152

10.6 Disclaimer 153

Licence Rights

Single User License:
Report can be used by individual purchaser only

Site License:
Report can be shared by unlimited users within one corporate location, e.g. a regional office

Corporate User License: 
Report can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company

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Products and Companies


Accord Healthcare

Alkem Laboratories




Archigen Biotech



Boehringer Ingelheim

Cadila Healthcare


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Cinfa Biotech


Claris Lifesciences

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CT Arzneimittel

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Dr. Reddy's Laboratories


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Fuji Pharma

Gedeon Richter

Glenmark Pharmaceuticals

Hetero Drugs




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Medice Arzneimittel Putter

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