Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment
- Published: April 2011
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Tapping Biosimilar Opportunities
Tapping Biosimilar Opportunities
- Published: September 2011
- Region: World
- 80 Pages
- MP Advisors
FEATURED COMPANIES
- Bharat Biotech
- Cipla
- Fujifilm pharma
- JCR Pharmaceuticals
- Nichi-iko
- Ranbaxy
- MORE
Tapping biosimilar opportunities
A Follow on biologic (FOB) or Biosimilar, as commonly known, has been one of the most widely discussed topics in the world of pharma in the last few years. The approaching patent expiry of biologic drugs worth US$ 79 billion during 2010-2015 represents a money-spinning opening for companies with the vital expertise.
The Global Biosimilars industry has witnessed a number of product launches and mergers & acquisitions in the past few years, as a result of the overstrain experienced due to rising healthcare costs, expensive drugs, ageing population and pharma expenditure.
Many biotech industries from India have plunged into the industry to develop biosimilars. They are also strengthening their activities towards developing standards and compendium activities in the fields of cell culture, virology and microbiology while working on chemical medicines as well.
The global development of biosimilars therefore represents a critical part of the future of biotechnology. This report titled 'Tapping biosimilar opportunities' covers the overview, market potential, segmentation and other critical aspects of biosimilars.
This
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EXECUTIVE SUMMARY
CHAPTER I: SECTOR PROSPECTS
The Opportunity WW
Regulated vs. non Regulated Markets
SWOT analysis of biosimilar market
Biosimilars approved in EU/US/Japan
Biosimilars currently marketed in India
Current Indian Players & emerging Players
CHAPTER II: REGULATORY GUIDANCE
Worldwide status of biosimilar guidelines
Comparative framework for biosimilar guidelines
Progression of legal & regulatory pathway in EU
Scenario in India
DCGI/ authorizing Body
Guidelines drafting
Time lines for Approval of Product/ Facilities
CHAPTER III: MARKET POTENTIAL
Marketed Biosimilars - Sales and projected sales for the next 5 yrs
Products targeted (EPO, G-CSF, Insulin, Mabs etc)
Market split for various biosimilars
Therapeutic areas with market potential
Biosimilars in advanced clinical development (pipeline)
Assessment of competitive scenarios
Cost of developing biosimilar & its effect on pricing (India perspective)
The beneficiaries
Indian companies with their biosimilars in development
Risks for Indian firms
CHAPTER IV: STRATEGIC VIEWS
Strategies used by companies to build capabilities in the biosimilars market
Alliances & partnerships
Emerging biosimilar business models
Capabilities needed by biosimilar players for achieving success
Commercialization strategies to maximize uptake & market potential
CRAMS in biosimilars: India advantage
CHAPTER V – A GLIMPSE OF THE ACTIVITIES OF INDIAN BIOSIMILAR COMPANIES WRT
Launched products
Current pipeline products
Manufacturing capabilities
Site audits & approvals
Partnerships
- BIOCON
- Dr.REDDY'S
- RELIANCE LIFE SCIENCES
- INTAS
- SHANTHA BIOTECH
- WOCKHARDT
- BHARAT BIOTECH
- RANBAXY
- CIPLA
- LUPIN
CHAPTER VI - JAPANESE & KOREAN COMPANIES GEARING UP FOR THE OPPORTUNITY
APPENDIX – THE ESSENTIALS OF BIOSIMILARS
- FOB, Biosimilars- A Rose by any name
- Expression Systems-Microbial, yeast, mammalian
- Biologics -Traditionally complex nature as compared to small molecules
- Biosimilars manufacturing processes
- Development cycle of Biosimilars
- Biocon
- Dr. REDDY'S
- Reliance Life Sciences
- Intas
- Shantha Biotech
- Wockhardt
- Bharat Biotech
- Ranbaxy
- Cipla
- Lupin
- JCR Pharmaceuticals
- Fujifilm pharma
- Fuji Pharma
-Nipro
- Nichi-iko
- Nippon Kayaku
- Hanwha chemical corporation
- LG life sciences
- Celltrion
- Green cross corp
- Samsung
| Format | Properties | |
|---|---|---|
| Electronic (PDF) | The report will be emailed to you. The report is sent in PDF format. | This is a single user license, allowing one specific user access to the product. |
| Site License | The report will be emailed to you. The report is sent in PDF format. | This is a site license, allowing all users within a given geographical location of your organisation access to the product. |
| Enterprisewide | The report will be emailed to you. The report is sent in PDF format. | This is an enterprise license, allowing all employees within your organisation access to the product. |
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