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.


GlobalData’s Biosimilars in Oncology 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.

Companies mentioned

Accord Healthcare

Alkem Laboratories




Archigen Biotech



Boehringer Ingelheim

Cadila Healthcare


Centus Biotherapeutics

Cinfa Biotech


Claris Lifesciences

Coherus BioSciences

CT Arzneimittel

Daewoong Pharmaceutical

Daiichi Sankyo

Dr. Reddy’s Laboratories


Emcure Pharmaceuticals

Fuji Pharma

Gedeon Richter

Glenmark Pharmaceuticals

Hetero Drugs




Intas Pharmaceuticals

Kissei Pharmaceutical

Kyowa Hakko Kirin




Medice Arzneimittel Putter

Meiji Seika Pharma

Merck & Co

Mochida Pharmaceutical


Nippon Kayaku


Panacea Biotec

Prestige BioPharma

Prolong Pharmaceuticals


Reliance Life Sciences

Samsung Bioepis


Synthon Holdings

Tanvex BioPharma


Torrent Pharmaceuticals



Zenotech Laboratories

Table of Contents

Table of Content (PowerPoint Deck)

1 Preface

1.1 Table of Contents

1.2 Related Reports

1.3 Upcoming Related Reports

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 GlobalData

10.5 Contact Us

10.6 Disclaimer


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