American Conference Institute's 6th Annual Summit on

Biosimilars

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


March 6, 2015: The FDA grants approval for the first Biosimilar under the BPCIA, Sandoz’s Zarxio. With this landmark decision, it is clear that the time for speculation and hesitation has passed.

For the past six years, since the passage of the historic Biologics Price Competition & Innovation Act (BPCIA) which first set the stage for biosimilars in 2010, the key figures shaping the evolving US biosimilars landscape have convened at our annual conference to formulate solutions to the challenges facing the industry. Now that the FDA has given its stamp of approval to at least one biosimilar and litigation is already winding its way through the Courts, don’t be left behind- arm yourself with an immediate action plan to prepare for the hard-fought battle to protect or increase market share which is sure to come.

Our accomplished faculty and our new Biosimilars Advisory Board — a veritable “Who’s Who” of the regulatory and intellectual property bars — have united to refresh this year’s agenda through new sessions reflecting the year’s biggest regulatory, IP, and policy developments.

Highlights of this year’s event include:

  • Direct insights from the FDA on the biosimilars approval process including making an interchangeability determination, demonstrating safety and efficacy, and designating a name for the biosimilar
  • A Judge’s panel featuring renowned jurists who will provide their insights into the issues involved in biosimilars litigation under the BPCIA and at the USPTAB
  • Policy insiders who will talk about the battles in the state courts over substitution and naming
  • Benchmarking against representatives from Boehringer, Genentech, Momenta, Fresenius, and many more featuring a new open floor town hall session to wrap up the conference

Whether you are on the innovator or biosimilars side, you will walk away with a nuanced plan for US biosimilars market entry.

We hope you will be part of the community and join your colleagues as we discuss what this year’s landmark developments mean to the future of healthcare and life sciences in the US at the premier event designed for the people shaping this law in the years to come. Call 1-888-224-2480, fax your registration to 1-877-927-1563, or visit us online.