“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:
- Detailed case study on the impact of Amgen Inc. v. Sandoz Inc. and related biosimilars litigation
- Analysis on the various partnerships, collaborations, and joint ventures between biotechnology and pharmaceutical companies to develop a biosimilar product
- Dissecting IPR trends and statistics in the pharmaceutical industry, including an exhaustive study of the Supreme Court’s holding in Cuozzo Speed Technologies, LLC v. Lee
- Examination of FDA’s proposed naming guidance and the potential impact on current and future biosimilars
- Biosimilars patent strategies under new section 101 and 112 case law
- Considerations for promotion of biosimilar products, including an exploration of potential off-label and products liability issues
- Preparing to transition NDAs to BLAs in 2020 under the BPCIA
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.