American Conference Institute’s 7th Annual Summit on
Legal, Regulatory, Commercial, and Patent Strategies for the Emerging U.S. Biosimilars Landscape
Monday, June 13 to Tuesday, June 14, 2016
New York Marriott Downtown, New York, NY
“As of January 21, 2016, 59 proposed biosimilar products to 18 different reference products were enrolled in the Biosimilar Product Development (BPD) Program . . . . Over the past year, we have seen the number of meeting requests and marketing applications grow. We are excited about this growing demand, and we will continue to facilitate development, submission, and timely review of biosimilar product applications.”
Testimony of Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Before the Committee on Energy and Commerce, Subcommittee on Health, United States House of Representatives (Feb. 4, 2016).
On March 6, 2015, the FDA approved Sandoz’s Zarxio, the first biosimilar product in the U.S. Just one year later, on April 5, 2016, FDA approved the second biosimilar product, Celltrion’s Inflectra. It is clear that innovator and biosimilar companies must develop a comprehensive strategy for the upcoming battles to protect or increase market share in this space.
Based on industry demand, ACI is proud to bring you the leading event on biosimilars, comprised of industry insiders who are actively shaping the evolving U.S. biosimilars landscape. At this annual conference, the esteemed faculty will provide you with real-life strategies designed to meet the year’s biggest legal, regulatory, and IP challenges. Designed with input from the industry and the distinguished members of ACI’s Biosimilars Advisory Board, this year’s event features several new sessions aimed at giving you unique, up-to-the-minute information for biosimilars:
In addition, don’t forget to join us for a comprehensive post-conference workshop delving into legal ethical and professional responsibility concerns for attorneys in the biosimilars space.
Whether you are on the innovator or biosimilar side, you will walk away with a comprehensive plan for biosimilars market entry in the U.S.
Join the leaders of the biosimilars industry and learn to navigate your way through the various legal, regulatory, commercial, and IP hurdles impacting your business. Save your spot by calling 888-224-2480 or by visiting online.
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Mon, Jun 13, 2016
Tue, Jun 14, 2016
New York Marriott Downtown
New York, NY