Biosimilars are here: that which we once contemplated is now a reality.Title VII of the Patient Protection and Affordable Care Act (PPACA),i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA) allows for an abbreviated pathway for biological products. As a result, biosimilars are now a reality. However, many questions remain regarding the implementation and logistics of developing biosimilars.
Prepare now for this new reality!In response to this,
American Conference Institute, the leading provider of legal conferences for the life sciences industries and creator of the original and preeminent forums on
Maximizing Patent Life Cycles and
Paragraph IV Disputes, has developed this timely event to provide you with the most in-depth analysis of the legal, regulatory, policy and business issues surrounding follow-on biologics. Based on your feedback, an outstanding faculty of government representatives, in-house counsel and leading legal practitioners will dissect the nuances of the legislation and provide you with insights and guidance on how to prepare for this groundbreaking new legislation. Unlike any other event, this conference will bring you:
- An in-depth view and behind the scenes discussion of the development of follow-on biologics led by industry insiders from the Hill.
- A realistic analysis and assessment of the financial viability of follow-ons including the assessing the barriers to entry, regulatory hurdles and the potential profit margins.
- A clear understanding of the complexity of biosimilarity in addition to methods for proving or disproving interchangeability.
- An exhaustive analysis of the patent resolution mechanisms as well as preemptive strategies for preparing for follow-on litigation.
- Global perspectives on the practical impact of biosimilars in Europe and beyond.
- Industry guidance on proving the safety of follow-on biologics and methods for quickly facilitating the development of safety data for future products
In addition, add value to your experience by attending the interactive Post Conference Workshop:
Applying Patent Term Adjustments and Patent Term Extensions to Biosimilars to Optimize the Biologic Patent Lifecycle. This hands-on session will provide you with practical advice, as well as tips and techniques for how to extend your patent. The session leader will take you through the intricacies of the major ways of getting an extension on your patent, and provide you with the tools that you need to accomplish this goal in this time of changing rules and regulations.
With all that’s at stake, you cannot afford to miss this conference.
