Visiongain will be holding its 4th Biosimilars conference on November 11-13, 2008 in Philadelphia, PA.  The conference is intended to help attendees:

• Identify the trends that will shape future market development of follow-on biologics;
• Explore the current market and regulatory environment for biosimilars in Europe and the relevance to U.S. legislation;
• Examine the emerging market landscape for biosimilars in India and China;
• Understand interchangeability/substitutibility policies;
• Discuss unwanted immunogenicity issues for biosimilars;
• Analyze the market impact of biosimilars from the payers perception;
• Examine the pre-marketing hurdles and post-marketing challenges faced by biosimilar/follow-on biologics developers;
• Utilize new and established analytical tools for demonstrating comparability; and
• Assess how is the landscape evolving for biosimilar medicines.

In particular, Visiongain faculty will offer presentations on the following topics on November 12-13:

• The biosimiliar threat:  Lessons learned from the European Union;
• Biosimilars in the EU;
• Examining the current legal and regulatory landscape for U.S. marketing of follow-on biologics;
• What is a Generic Biopharmaceutical?  Biogeneric?  Biosimilar?  Follow-on Biologic?
• Strategies for achieving the most effective patent protection;
• The future role biosimilars can play in improving patient access to effective and affordable medicines;
• The market for biosimilars: evolution and policy options;
• Potential competition implications for generic biologics;
• Examining the emerging market landscape for biosimilars in India;
• Development of G-CSF biosimilar:  A win-win-win situation on three continents;
• Biosimilar commercialization opportunities and challenges in the U.S.;
• Understanding the regulatory framework surrounding the development of biosimilars;
• The commercial implications of biosimilars:  The experience in Europe;
• The next generation of biosimilars;
• Understanding pricing and reimbursement issues; and
• New and established analytical tools for demonstrating comparability.

In addition, a pre-conference interactive biosimilars workshop will be offered on November 11.  The agenda for the Biosimilars conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here (free registration required).

The registration fee ranges from £1299 ($1880) for the conference alone to £1699 ($2460) for the conference and workshop; the fee for attending the workshop alone is £599 ($867).  Academic discounts are available.  Those interested in registering for the conference can do so here.