Original air date: August 27, 2015. Biosimilars: Regulation, Litigation & New Development Patent Practitioners & Regulatory Attorneys Should Know
The speakers will review the FDA regulatory pathway for biosimilars in the U.S. 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 U.S. and abroad will also be reviewed, as well as the new Guidance documents published by the FDA.
Presented by: James Shehan of Human Phelps & McNamara, PC; Sanya Sukduang of Finnegan Henderson Farabow Garrett & Dunner, LLP; Debora Plehn-Dujowich of Prismatic Law Group, PLLC; moderated by Carla Mouta of Finnegan Henderson Farabow Garrett & Dunner, LLP.