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Hear from Top US and International Biologics Experts at ACI's 8th Annual Summit on Biosimilars
With 5 biosimilars now approved, a potential repeal of Obamacare, and a groundbreaking decision expected later this year on the Amgen-Sandoz SCOTUS case, there has never been a more critical time to hear from thought leaders on these important developments. Highlights of this year's event include:
- Review of the first 18 Months of Biosimilars and a Look into the Future
- Up-to-Date Analysis of Amgen v. Sandoz and Sandoz v. Amgen
- Interchangeability and FDA's Recent Guidance, "Considerations in Demonstrating Interchangeability with a Reference Product"
- Mastering the Steps and Challenges of the BPCIA
- IPRs for Biosimilars
- Naming and Suffixes for Biosimilars
- Labeling Compliance and FDA's Draft Guidance, "Labeling for Biosimilar Products"
- Product Liability Litigation, Pricing, and Reimbursement for Biosimilars
- Judicial Perspective on Biosimilar Litigation
Brand new this year are our interactive workshop sessions on Navigating Section 101 and 112 Patentability Challenges, and Strategies for Creating an International Biosimilar Portfolio.
Our program includes insights from our Biosimilars Advisory Board as well as in-house representatives from companies such as Amgen, Association for Accessible Medicines, BIO, Biogen Inc., Boehringer Ingelheim, Coherus Biosciences Inc., Eisai Inc., Endo Pharmaceuticals Inc., Momenta Pharmaceuticals, National Council for Prescription Drug Programs, Novo Nordisk, Regeneron Pharmaceuticals, Inc., and Sanofi.
Bruce Leicher, Senior Vice President and General Counsel at Momenta Pharmaceuticals Inc., says "For nearly a decade, the ACI Biosimilars Meeting has provided participants with a sightline into a broad cross section of policy positions, timely updates, and education on key biosimilar strategies. The diversity of views makes this meeting stand out from many others." A member of our esteemed Advisory Board, Bruce, who will be speaking on interchangeability, joins our stellar faculty of Judges, prestigious law-firm leaders, and in-house counsel as they delve into the ins and outs of succeeding in the biologics marketplace.
Full information on the forum can be found at http://www.AmericanConference.com/