Events
Duane Morris Partner Anthony Fitzpatrick to Review "Biosimilars: Emerging Legal Challenges"
December 6, 2011 | Webinar
Duane Morris partner Anthony Fitzpatrick will be speaking at a Strafford webinar entitled "Biosimilars: Emerging Legal Challenges" on Tuesday, December 6, 2011, from 1:00 p.m. to 2:30 p.m.
Speakers 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. For additional information, or to register, please visit the Strafford website.
