Biosimilars - The Future Transformation of Product Exclusivity in the Biotechnology Arena
出 版 商：CBR Pharma Insights
出版日期：2009/06/15
頁 數：53頁
文件格式：PDF
價 格：
USD 3,900 (Single-User License)
USD 4,900 (Multi-User License)
USD 9,800 (Global-User License)
USD 4,900 (Multi-User License)
USD 9,800 (Global-User License)
Biosimilars - The Future Transformation of Product Exclusivity in the Biotechnology Arena
Summary
The nature of biotechnology has, up until recently, prevented the threat of generic intrusion on product sales. Biologics are difficult to replicate compared to small molecules and even slight differences in manufacturing processes could lead to significant clinical differences.
The US government is poised to address the need for a process by which “similar” biologics or proteins can be approved and brought to market. Two legislations are on the table, one more closely resembling recently enacted laws in Europe.
This report uncovers how the US biotechnology and biopharmaceutical industry will soon change in dramatic ways as we see the introduction of biosimilars. While the actual laws and legislation that will usher in this new era have yet to be finalized, players are already setting up to be the first to take advantage of any new opening for this competitive biotech arena.
Scope
- Overview, history and Biosimilar landscape
- Biotech patent exclusivity precedence
- Laws and legislation related to biosimilars
- Profiles of top biosimilar players
- Future outlook
Reasons to buy
- CBR Pharma Insights identifies and discusses the key issues and potential changes surrounding the landscape of biosimilars and their future impact on the biotechnology industry
- Gain access to CBR Pharma Insights’ analysis around the legislation which will usher in a new era of competition in the biotechnology arena
- Visualize the companies, products & sales forecasts which could be impacted the most in the near term and from which biosimilar companies
- Gain insight from our biosimilar industry interviews as key comments and viewpoints are delivered throughout the report
- Understand better the challenges around biosimilar product development and how these challenges could provide a strong defense for innovator companies
- Benefit from our conclusions and future insights to best support your understanding and key decisions around the potential changes to the biotechnology industry
Summary
The nature of biotechnology has, up until recently, prevented the threat of generic intrusion on product sales. Biologics are difficult to replicate compared to small molecules and even slight differences in manufacturing processes could lead to significant clinical differences.
The US government is poised to address the need for a process by which “similar” biologics or proteins can be approved and brought to market. Two legislations are on the table, one more closely resembling recently enacted laws in Europe.
This report uncovers how the US biotechnology and biopharmaceutical industry will soon change in dramatic ways as we see the introduction of biosimilars. While the actual laws and legislation that will usher in this new era have yet to be finalized, players are already setting up to be the first to take advantage of any new opening for this competitive biotech arena.
Scope
- Overview, history and Biosimilar landscape
- Biotech patent exclusivity precedence
- Laws and legislation related to biosimilars
- Profiles of top biosimilar players
- Future outlook
Reasons to buy
- CBR Pharma Insights identifies and discusses the key issues and potential changes surrounding the landscape of biosimilars and their future impact on the biotechnology industry
- Gain access to CBR Pharma Insights’ analysis around the legislation which will usher in a new era of competition in the biotechnology arena
- Visualize the companies, products & sales forecasts which could be impacted the most in the near term and from which biosimilar companies
- Gain insight from our biosimilar industry interviews as key comments and viewpoints are delivered throughout the report
- Understand better the challenges around biosimilar product development and how these challenges could provide a strong defense for innovator companies
- Benefit from our conclusions and future insights to best support your understanding and key decisions around the potential changes to the biotechnology industry
Executive Summary
Introduction
History of biotechnology
Biotech patent exclusivity precedence
Semantics of biotech “generics”
Laws and legislation
European legal precedence
Legal pathways under consideration
Potential impact of likely scenarios
Biosimilar Landscape
Pivotal products & impacted innovator companies
Profiles of top biosimilar players
Conclusion: The future of biosimilars in the US
Learning from Europe
The changing U.S. biotech industry
Industry expert comments
Appendix
Introduction
History of biotechnology
Biotech patent exclusivity precedence
Semantics of biotech “generics”
Laws and legislation
European legal precedence
Legal pathways under consideration
Potential impact of likely scenarios
Biosimilar Landscape
Pivotal products & impacted innovator companies
Profiles of top biosimilar players
Conclusion: The future of biosimilars in the US
Learning from Europe
The changing U.S. biotech industry
Industry expert comments
Appendix
