Orange Book Blog

It's been two years since Congress passed the Biologics Price Competition and Innovation Act, and FDA is still waiting to receive the first biosimilar application.  But that doesn't mean progress hasn't been made.  FDA issued three draft guidance documents in February, and various companies and industry groups have submitted comments on the guidance (see this GEN article for a summary of the comments).  On May 11, FDA will hold a public hearing to receive additional input on the draft guidance.

American Conference Institute's 3rd Advanced Forum on Biosimilars, taking place May 22-23 in New York City, will address these developments and more.  The agenda includes the following presentations:

• Implementing the Biosimilar Pathway: FDA Guidance and Planning for the U.S. Biosimilars Regime
• Answering the $100 Million Question: Evaluating the Commercial Viability and Opportunity of Biosimilars
• Defining Biosimilarity and Meeting the Additional Statutory Standards for Interchangeability
• Practical Implications of a 12-Year Exclusivity Period: Strategically Defining and Calculating Exclusivity
• The Biosimilars Experience: Providing an Optimal Patient Encounter
• Overcoming Biosimilars Regulatory, Marketing, and Commercialization Challenges
• In-Depth Breakdown of the Biosimilar Framework in the EU: Risk Management Strategies to Protect your Biologic on the International Stage
• The First Wave of Litigation: Proactive Procedures and Early Considerations for Innovators and Biosimilar Companies
• Timing is Everything: A Checklist to Ensure Preparedness for Litigation
• The Post-AIA World: Factoring the Impact of Patent Reform into Biosimilars Prosecution and Litigation Strategies
• Understanding FDA's Requirements for Biosimilars Clinical Trials
• Safeguarding Intellectual Property and Maximizing Biologic Patent Life Through a Robust Biosimilars Patent Portfolio Strategy
• BLAs, Biobetters and Beyond: Evaluating the Benefits and Risks of Alternative Routes to Market

In addition, ACI is offering a pre-conference primer on Monday, May 21:  "Biologics 101: Formulating a Biosimilars Patent Portfolio Development Plan Grounded in Complex Scientific Properties."   ACI is also offering a post-conference master class on Thursday, May 24:  "Maximizing Market Share in a Global Economy: Exploring Opportunities for Biosimilars Growth into Emerging Markets."

For more information or to register, please visit the conference website.  For a $200 discount on registration fees, use discount code OBB 200.