Biosimilars: A Growing Market
Urch Publishing
March 1, 2010 60 Pages - SKU: URC2615920
|
|
Although a number of major companies have significant biological capabilities, few apart from Novartis have yet clearly developed strategies to compete in the biosimilars market
Since Sandoz pioneered the development of biosimilar drugs in 2001 there has been a steady breakdown of regulatory resistance. However, there are considerable entry barriers hindering companies that wish to enter this field of therapeutics.
Biosimilars - A Growing Market is a unique report from URCH Publishing that provides the reader with a comprehensive review of the current and future market for biosimilar products,
Some key findings from the report:
- Few companies apart from Novartis have yet clearly developed strategies to compete in the biosimilars market.
- The biosimilars market segment is poorly developed but is expected to become a significant commercial segment capturing a healthy percentage share of the biologicals market.
- Many forecasts of the biosimilars market are over-optimistic, and assume a rapid resolution of the legislative impasse in the US and overlook the strength of Amgen’s patent position with respect to epoetin alfa.
- Assuming a later passing of US legislation the value of the biosimilars market segment will continue to be dominated by European sales revenues in 2012, and this is likely to account for about 0.6% of the fast-growing biologicals market.
- The anti-TNF segment offers the best commercial opportunity with the three leading products all likely to face competition from biosimilars in Europe by 2016.
|
- Executive Summary
- Chapter 1: Introduction
- Introduction
- Drugs and generics
- Biological products
- What is a biosimilar?
- Developments, 2000-09
- New commercial opportunities
- Chapter 2: Approval of Biosimilars
- Overview
- Europe
- Data requirements
- Assessment process
- US
- The FDA
- FTC
- Congress
- Assessment of the position
- Japan
- Other markets
- Chapter 3: Entry Barriers
- Contrast to conventional generics
- Development issues
- Manufacturing issues
- Patent considerations
- Distribution channels
- Price impact
- Chapter 4: The Emergent European Market in Biosimilars
- Introduction
- Current status
- Rejected applications
- Human growth hormone biosimilars
- Erythropoietin biosimilars
- Filgrastim biosimilars
- Impending launches
- Current assessment
- Chapter 5: Significant Commercial Opportunities
- Introduction
- Leading biotechnology products
- When do current biotechnology products go off patent?
- Europe
- US
- Epoetin litigation
- Japan
- Summary of opportunities
- Market assessment
- Chapter 6: Strategic Developments
- Introduction
- New specialist companies
- 3SBio
- Bharat Biotech
- Biocon
- Bioton
- Dragon Pharmaceuticals
- Intas Pharmaceuticals
- Lonza AG
- Panacea Biotec
- Reliance Life Sciences
- Shantha Biotechnics
- Response of the generics companies
- Novartis (Sandoz)
- Dr Reddy's
- Hospira
- LG Life Sciences
- Mylan
- Ranbaxy
- Ratiopharm
- Stada
- Teva
- Wockhardt
- Big pharma's response
- AstraZeneca
- Merck
- Pfizer
- Overview
- Chapter 7: Market Outlook
- Commercial factors
- Biosimilar substitution
- Pricing
- Cost savings
- Strategic drivers
- Emerging opportunities
- Europe
- US
- Japan
- Commercial overview
- Epoetins
- G-CSF
- Interferons
- Anti-TNF products
- Oncology and other antibodies
- Financial forecast
- List of Figures
- Figure 1.1 2008 sales and year of launch of leading biological products
- Figure 2.1 Market exclusivity for reference products and timing of biosimilar Marketing Authorisation Applications (MAAs)
- Figure 2.2 Centralised procedure for MAAs
- Figure 2.3 Number of new biologics approved in Japan, 2001-08
- Figure 4.1 Biosimilar MAAs submitted for initial evaluation
- Figure 5.1 Worldwide sales of biological products by patent expiration year and 2008 revenues of those products
- Figure 5.2 Approval of new biological agents in Japan, 2001-08
- List of Tables
- Table 2.1 Quantity of data required for MAAs for generic and biosimilar products (as number of lever-arch files)
- Table 2.2 Data requirements for MAAs for generic and biosimilar products
- Table 5.1 Leading biotechnology therapeutics (excluding insulin derivatives and vaccines) showing reported global sales for 2007 and 2008
- Table 5.2 Top 11 classes of biotechnology therapeutics (excluding vaccines) showing reported global sales for 2007 and 2008
- Table 5.3 Expiration dates of market exclusivity of key biological products in the major European countries
- Table 5.4 Expiration dates of market exclusivity of key biological products in the US
- Table 5.5 Amgen's key epoetin patents in the US
- Table 5.6 Approval dates of selected biological products in Japan
- Table 7.1 Timeline of anticipated key events, 2010-17 (those in the US and Japan assume that legislation is enacted as discussed)
Share this report
Other tasks Related Markets Research & Development Reports Free Alert Me service Receive bi-weekly email alerts on new market research Sign Up Today!
|
