American Conference Institute’s 8th Annual Summit on Biosimilars

About the Event

The premier event where industry leaders from both innovator and biosimilar companies discuss the future of biosimilars with regards to regulations, patents, and game-changing legal developments.

With four biosimilars (products interchangeable with FDA-licensed biological products) approved in the U.S. and many more applications currently before the FDA, the business of biosimilars seemed to be in full swing in 2016.  Now, due to a new administration and the potential repeal of the ACA, the future of biosimilars is currently uncertain.

Potential topics to be discussed this year include:

• The status of the Biologics Price Competition and Innovation Act (BPCIA) cases to date and the future of the Affordable Care Act.
• Insights into FDA’s current and future initiatives.
• Overview and analysis of the seven ongoing biosimilar litigations.
• The flourishing U.S. biosimilars market and evaluating its risk and commercial opportunity
• Creating biosimilar patent itigation strategies involving both inter-parties review and new U.S. Patent and Trademark Office procedures.
• Controversies surrounding competition, substitution, and naming in the biosimilars arena.

Date
June 12 - 14, 2017

Monday, June 12, 2017
8:00 AM - 5:30 PM EST

Tuesday, June 13, 2017
8:45 AM - 5:00 PM EST

Wednesday, June 14, 2017
9:00 AM - 5:00 PM EST

Location
InterContinental New York Times Square 
300 W 44th Street 
New York, NY 10036

Hon. Garrett E. Brown, Jr. (Ret.)

Judges Speak: Inside Perspectives on Biosimilar Litigation
Tuesday, June 13, 2017 | 2:30 PM - 3:45 PM EST