Strafford
will be offering a webinar/teleconference entitled "Biosimilars: Navigating FDA's Evolving
Approval Pathway, Protecting Patents and Trade Secrets" on October
9, 2013 from 1:00 to 2:30 pm (EDT). Howard W. Levine of Finnegan Henderson
Farabow Garrett & Dunner and Patent Docs author Dr. Kevin E. Noonan of
McDonnell Boehnen Hulbert & Berghoff will provide a drill-down on the FDA's
2013 draft guidance to navigate the complex standards of the FDA's Biosimilar
Approval Pathway and address the most challenging issues around patent and
exclusivity in developing, marketing, and obtaining approval for biosimilars in
and outside the U.S. The webinar
will review the following questions:
• How will the latest draft guidance impact
protection for biosimilars?
• What are the FDA's definitions for "highly
similar" and "interchangeability"?
• What are the market protection issues raised by
patent exchange procedures for biopharmaceuticals?
• What is the criteria for the 12-year exclusivity
period?
The
registration fee for the webinar is $297 ($362 for registration and CLE processing). Those registering by September 13, 2013 will
receive a $50 discount. Those interested
in registering for the webinar, can do so here.
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