American Conference Institute’s 5th Annual conference on:


The Definitive Forum on the Legal, Regulatory, Patent, and Commercial Realities of Biosimilars

Wednesday, June 04 to Friday, June 06, 2014
InterContinental New York Barclay, New York, NY

Attend the premier event where the industry leaders from both branded and biosimilar companies convene to formulate solutions to the complex regulatory and patent challenges ahead as the first wave of biosimilars become a reality in the U.S

At long last, the first biosimilar application seems imminent: The closed-door meetings between FDA and industry continue to escalate even in the face of uncertainty surrounding the final regulations, and a lawsuit surrounding the complicated BPCIA litigation provisions hit the courts even before the first application as a sign of the hard-fought battles to come. 

Since the passage of the historic Biologics Price Competition & Innovation Act (BPCIA) in 2010, the key figures shaping the evolving biosimilar landscape--- leading policy makers, in-house representatives from branded and generic biotechnology and pharmaceutical companies, and top-tier litigators and patent prosecutors--- have convened to formulate solutions to the challenges facing the industry including: 

  • Meeting FDA’s requirements for biosimilarity and the heightened standard of interchangeability: what will biosimilar companies need to show in terms of safety data?
  • Assessing the actual costs of bringing a biosimilar to the market based on the relevant regulatory, scientific and legal factors and predicting the first biosimilar challenges based on the current pipeline
  • Understanding the battle over naming and substitution on the state level and examining the implications of these bills on competition in light of the FTC hearing
  • Preparing for the first wave of biosimilar litigation: how will the massive changes under the AIA affect your biosimilars prosecution and litigation strategies?
  • Analyzing the arguments in the first BPCIA case, Sandoz Inc. v. Amgen Inc.: how should innovator and biosimiar companies be preparing now for the strict timelines once the first applications are filed?

In the face of the looming patent cliff, with an estimated $50 billion in biologics patents expiring by 2020, biosimilars remain a tantalizingly promising area for biopharmaceutical companies to maintain and grow lucrative market share.  Despite the uncertainty, there is a sky-high potential for growth into the untapped domestic biosimilars market, and now is the time to position your company amongst the leaders.  Whether you are on the biosimilar or innovator side, do not miss this opportunity to remain at the forefront of this burgeoning opportunity.

Hear What Prior Attendees are Saying about this Annual Leading Event:

  • “One of the best CLEs I’ve been to in 10 years”
  • “Excellent program – informative and thought-provoking.”
  • “I thought all the speakers did an excellent job in terms of content and delivery.”
  • “Excellent seminar.  A lot of learning, new points of view talked about and dealt with.”
  • “Panels were very good- relevant to my practice and thought provoking”
  • “Very important topic- I will attend again”
  • “Interesting topics and well organized”
  • “Both the conference and the pre-conference workshops were great!”

For information on sponsoring or exhibiting at this event, contact Esther Fleischhacker at

Based on past success, spaces will fill up quickly. Register now by calling 888-224-2480, faxing your registration form to 877-927-1563 or registering online at