CBI Conference Will Evaluate the Legal, Regulatory and Economic Landscape in the U.S. and Abroad for Biosimilars and Follow-On BiologicsFebruary 6, 2009
The Center for Business Intelligence (“CBI”) will hold its 2nd Annual Summit on Biosimilars and Follow-On Biologics on March 10-11, 2009. The Conference will be held at the Marriott Baltimore Inner Harbor at Camden Yards in Baltimore, Maryland. A copy of the conference brochure is available here. Hyman, Phelps & McNamara’s Kurt R. Karst will present at the conference on the patent and non-patent market exclusivity provisions of follow-on biologic legislation that has been introduced.
The CBI conference is intended to provide participants with the opportunity to evaluate follow-on biologic legislation while also investigating the guidelines being used in other countries – and most importantly, how these guidelines have affected company strategies, profits and the economic landscape. Key topics to be addressed at the conference include:
• WHO Guidance, expectations and implications for globally accepted biosimilar standards
• The similarities, differences and potential impact of Canadian biosimilar legislation
• Naming concerns for biosimilar products and post-launch tracking
• The FTC’s perspective on biologic fair competition
• The exclusivity issues in proposed legislation
• Lessons learned from pharmaceutical patent litigation
• How the criteria for comparability is being/should be established
• The economic implications of the EU approval pathway
• The testing, distribution and pricing of biosimilars in India, China and Brazil
Special FDA Law Blog Discount – CBI is offering FDA Law Blog readers a $400 discount off of the registration fee. To register for the conference, go to the CBI website and enter the following code – KZG958.