McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar on the "The Biosimilar Drug Approval Pathway: Draft FDA Guidance and Beyond" on March 27, 2012 from 10:00 am to 11:15 am (CT). Patent Docs authors and MBHB attorneys Dr. Kevin Noonan and Dr. James DeGiulio will provide a detailed analysis of the three biosimilar guidance documents published by the U.S. Food and Drug Administration on February 9, 2012, including:
• What the guidance materials say and what they don't;
• Early impressions and reactions to the biosimilar guidance documents;
• Lessons from the guidance and practical applications;
• Effect of the guidance on the 351(k) abbreviated pathway;
• Biosimilar proposal status update; and
• Impact of the BPCIA and biosimilar guidance on other aspects of patent law.
The presenters will also discuss the possibility that the combination of these non-specific guidances and the complex litigation provisions of the law may provide incentives for biologic drug innovators to rely more heavily on the market exclusivity provisions of the Act than on patents, and the implications of this eventuality.
While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here. CLE credit is pending for the states of California, Georgia, Illinois, North Carolina, New Jersey, New York and Virginia.