American Conference Institute's 7th Annual Summit on

Biosimilars

Monday, June 13 to Tuesday, June 14, 2016
New York Marriott Downtown, 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 are a reality in the U.S

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.

Just last year, over 140 industry leaders converged in NY at this event to discuss the first U.S. biosimilar applications. While the first biosimilar came on market in September, there are still many questions outstanding and the patent dance has already begun for these products in both Federal Court and the PTAB. With the second wave of applications on the horizon and more guidance on the way, it is more important than ever to get the most updated cutting edge information from the leading authorities in this rapidly developing and critical space. Topics to be discussed this year include:

  • Insights into FDA’s current initiatives regarding the first wave of biosimilars applications and what to expect in the second wave including the status of final guidance on FDA’s standards for interchangeability and labeling
  • Navigating the burgeoning US biosimilars market and evaluating the risk and commercial opportunity
    • Reviewing the BPCIA cases filed and decisions to date including 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 controversies surrounding competition, substitution, and naming in the biosimilars arena

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

  • “Very good speakers and good selected topics. I especially like to see the panels on FDA and economic topics, as these are important, but less frequently addressed.”
  • “Very good and informative.”
  • “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 Bolam Kim at b.kim@americanconference.com. For information on sponsoring or exhibiting at this event, contact Esther Fleischhacker at e.fleischhacker@americanconference.com.

Based on past success, spaces will fill up quickly. Register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563, or registering online.