Hyman Phelps and McNamara
 
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James C. Shehan is co-presenting at the American Intellectual Property Law Association Webinar - Biosimilars: Regulation, Litigation and
August 27, 2015

12:30 to 2 pm

The speakers will review the FDA regulatory pathway for biosimilars in the US and how biosimilar applicants may use data obtained abroad in certain cases. Issues surrounding litigation for biosimilars will also be covered, such as whether the “patent dance” is optional, and whether other routes such as PTAB trials should be pursued. Recent developments in biosimilar applications in the US and abroad will also be reviewed, as well as the new Guidance documents published by the FDA.



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