Bio Ethics

Bio Ethics

4th Annual Biosimilars Conference Ensuring quality, safety, and performance of follow-on biologics

>> Tuesday, July 01, 2008

9th - 11th July 2008, Philadelphia, USA

Visiongain is delighted to host the 4th Annual Biosimilars conference in Philadelphia this July.
This 3-day event will provide you with practical insights into the scientific developments and regulatory challenges that will influence the success of biosimilars/follow-on biologics market. Enabling you with a platform to discuss the issues effecting the market, such as product selection and payer acceptance in a broader industry context. Consideration will be given to the evaluation of unwanted immunogenicity of follow-on biologicals, from preclinical development, through clinical trials, and into the post-registration period to minimise the risks associated with immunogenicity in recipients of therapeutic products.

Topics covered :
• The biosimilar threat: Lessons learned from the European Union
• Understanding the regulatory framework surrounding the development of biosimilars
• Examining the current legal and regulatory landscape for US marketing of follow-on biologics
• Strategies for achieving the most effective patent protection
• The future role biosimilars can play in improving patient access to effective and affordable medicines
• Ensuring patient safety and clinical efficacy
• Potential competition implications for generic biologics
• Examining the emerging market landscape for biosimilars in India
• Opportunities and challenges for biologics in China
• Biosimilar commercialisation opportunities and challenges in the US
• The next generation of biosimilars
• New and established analytical tools for demonstrating comparability

Contact:
Andres Arias, Visiongain Ltd.
pharma.reports3@conferencesandreports.com

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