American Conference Institute's 6th Annual Summit on


The Definitive Forum on the Legal, Regulatory, Patent, and Commercial Realities of Follow-On Biologics

Monday, June 01 to Wednesday, June 03, 2015
Affinia Manhattan, New York, NY

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

At long last, companies are officially moving forward with the first U.S. biosimilar applications and the FDA has given its stamp of approval to at least one. As a sign of the hard-fought IP battles to come, multiple lawsuits have been filed under the BPCIA, even in the absence of final FDA guidance.

Since the passage of the historic Biologics Price Competition & Innovation Act (BPCIA) in 2010, the key figures shaping the evolving biosimilar landscape---in-house counsel from leading biopharmaceutical companies, top IP and regulatory lawyers, key policy and industry insiders, the FDA, and the FTC- have convened to formulate solutions to the challenges facing the industry at the ACI Biosimilars conference. Topics to be discussed this year include:

  • Insights into FDA’s current initiatives regarding the first wave of biosimilars applications: status of final guidance and updates on meeting FDA’s standards for biosimilarity and interchangeability
  • Navigating the burgeoning US biosimilars market and evaluating the risk and commercial opportunity
  • Reviewing the BPCIA cases filed to date including Sandoz v. Amgen and Celltrion v. Janssen: strategies for declaratory judgment actions, preliminary injunctions, and more
  • Incorporating inter-partes review and new USPTO procedures into branded and biosimilar litigation strategies
  • Update on the controversy surrounding competition, substitution, and naming in the biosimilars arena

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!”

Full conference details are on the way shortly. If you are interested in speaking at this event, contact Nicole Cutrufello-Turner at 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