CBI Conference Will Evaluate the Legal, Regulatory and Economic Landscape in the U.S. and Abroad for Biosimilars and Follow-On Biologics

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.