Strafford will be offering a webinar entitled "Biosimilars: Emerging Legal Challenges" on December 6, 2011 from 1:00 - 2:30 PM (EST). Anthony Fitzpatrick of Duane Morris and Daniel Kracov of Arnold & Porter will provide a review of the complex standards of the Biosimilar Approval Pathway and address patent and exclusivity concerns around the development and marketing of biosimilars including information exchanges, infringement issues, and sameness and interchangeability questions. The webinar will review the following questions:
• 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?
An interactive Q&A session will follow the presentation.
The registration fee for the webinar is $297 ($362 for registration and CLE processing). Those registering by November 11, 2011 will receive a $50 discount. Those interested in registering for the webinar, can do so here.
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