FDA to give guidance on biosimilars approval pathway at ACI Biosimilars conference
More timely than ever in light of just-released FDA guidance on the abbreviated pathway and impending public comment hearings,
As Senior Vice President and General Counsel for Momenta Pharmaceuticals Bruce A. Leicher states, “With the recent publication of FDA's biosimilar guidance documents and the public hearing planned for May 11, the ACI Biosimilars conference offers a timely opportunity to share perspectives and increase understanding of the new approval pathway for biosimilar development and commercialization."
Last June, over one hundred life sciences industry insiders gathered to proactively plan strategies to prepare for the implementation of the biosimilars pathway. This year, the industry buzz is surrounding a new addition to the program – Denise Esposito, Deputy Associate Director of Policy, Office of Regulatory Policy (ORP), CDER at the Food and Drug Administration (FDA) is confirmed to give a keynote address on Implementing the Biosimilar Pathway: FDA Guidance and Planning for the U.S. Biosimilars Regime.
In addition to the FDA keynote, attendees will hear industry leaders from the top market leaders including Amgen, Dr. Reddy’s, Eli Lilly, Merck, Momenta, Pfizer, and Sandoz share strategies to:
• COMPLY with the FDA’s proposed guidance on demonstrating interchangeability and defining biosimilarity
• DETERMINE the financial viability of biosimilars in light of the mandates in the guidance
• ASCERTAIN the level of clinical trials data which will be required to prove safety and efficacy
• EXPLORE new strategic alliances and alternative pathways to approval including biobetters
• ADAPT a practical approach to incorporate biosimilars into your current patent portfolio strategy to protect intellectual property and maximize the biologics life cycle
• PREPARING for the eventuality of patent challenges and brace for the flood of litigation sure to come
• EXTRAPOLATE lessons from global biosimilars product launches and increase expertise into biosimilars abroad in established and emerging markets
Click here for a full faculty list and agenda… Over 15 companies confirmed and counting…
Space will be limited… reserve your seat amongst the key thought leaders in the nascent biosimilars market today. With hundreds of billions in global biologics sales at stake, do not miss this opportunity to remain at the forefront of this long-awaited opportunity. Register today by calling 888-224-2480, fax your form to 877-927-1563, or online at www.AmericanConference.com/