Orange Book Blog

American Conference Institute is holding their 2nd annual "Biosimilars" conference in New York City on July 7th and 8th, at the Millenium UN Plaza Hotel.  According to ACI, this is "the definitive forum on the legal, regulatory, and commercial realities of generic biologics."

The agenda includes the following presentations:

• Update on current FDA position and initiatives regarding biosimilars
• Predicting, preparing and positioning for the FDA's implementation of the biosimilar pathway
• Scrutinizing the costs and complexities behind biosimilar research and development
• Debating the practical implications of a 12-year exclusivity period: Striking a balance between innovator and biosimilar interests
• No two biologics are alike: Defining biosimilarity and meeting the heightened standard of interchangeability under the statute
• Branding and promotional considerations for biosimilars
• Learning from the global development of biosimilars: Enforcement and risk management strategies to protect your biologic on the international stage
• An overview of the statutory dispute resolution mechanisms: Steering clear of any potential gaps in the litigation
• Developing proactive procedures and strategies today for the flood of biosimilar litigation tomorrow: From early planning through the exchange of patent lists
• Developing proactive procedures and strategies today for the flood of biosimilar litigation tomorrow: From the exchange of patents to be litigated to product launch
• Ascertaining the type and volume of clinical data necessary to establish biosimilarity
• Structuring a patent portfolio strategy to protect IP in light of FOB legislation
• Alternative routes to market for biosimilars: Evaluating the benefits of using the abbreviated pathway

In addition, there is a pre-conference science primer, "Biologics Science 101: Understanding and Deconstructing the Complicated Scientific Principles Behind Biosimilars," on June 6th; and a post-conference master class, "In-Depth Breakdown of the Biosimilar Framework in the EU," on June 9th.

Orange Book Blog readers can receive a $200 discount by using code OBB 200.  For more information or to register, please visit the conference website.