Biosimilars in Oncology
Summary
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.
Scope
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:
Reasons to buy
Summary
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.
Scope
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
3. Introduction
4. Biosimilars - Key Clinical and Commercial Concepts
5. Biosimilar Regulatory Pathways Across Geographies
6. Biosimilar Market Potential in the 9MM
7. Important Indications for Oncology Biosimilars
8. Major Players and Emerging Players
9. Current Market Dynamics and Future Outlook: Results from a High-Prescriber Survey
10. Appendix
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