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Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment
GBI Research, April 2011, Pages: 130
Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment
Summary
GBI Research, the leading business intelligence provider, has released its latest report, “Biosimilars Approval Pathways in the US and Europe – Development and Approval of Biosimilar mAbs May Face Tough Regulatory Environment” that provides key data, information and analysis of the major trends and issues affecting the global biosimilar market. The report provides a comprehensive insight into the biosimilar market. It offers geography-wise as well as category-wise market forecasts for biosimilars and provides the drivers and restraints affecting the biosimilars market. The report also talks about the business environment and the key success factors in the global biosimilar industry. The report also describes the regulatory environment in the US, top five European markets and Japan with respect to biosimilars. At the end, the report looks into the competitive landscape of the biosimilar industry by offering profiles of key players in the industry and the analysis of major deals that took place in the industry.
Scope
The report covers -
- Data and analysis on the biosimilar market in the leading geographies of the world – the US, the UK, Germany, France, Italy, Spain, and Japan.
- Market forecast for global biosimilar market from 2009 to 2016, geography-wise as well as product category-wise.
- Key drivers and restraints that have had a significant impact on the market globally as well as at national level.
- The regulatory environment for biosimilars in the US, the EU and in Japan.
- Analysis of competitive environment in the industry, profiles of key players in the biosimilar market. The companies studied in this report are Sandoz, Teva Pharmaceuticals, Hospira, Dr. Reddy’s, Biocon, Watson Pharmaceuticals, Biopartners, Reliance Life Sciences, Stada, Intas, Celltrion and 3S Bio.
- Key M&A activities and Licensing Agreements that took place between 2008 and 2010 in the global biosimilar market.
Reasons to buy
The report will enhance your decision making capability in a more rapid and time sensitive manner. It will allow you to -
- Make more informed business decisions from the insightful and in-depth analysis of the global biosimilar market and the factors shaping it.
- Identify the key areas of deal making through thorough understanding of the deals landscape in the global biosimilar market.
- Build effective strategies to launch the pipeline products by identifying potential geographies.
- Identify the companies from emerging nations for collaborations along with their key capabilities.
- Exploit in-licensing and out-licensing opportunities by identifying products that might fill your portfolio gaps.
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