Law Seminars International (LSI) will be offering a one-hour telebriefing on the "FDA's New Biosimilar Guidances" on May 15, 2012 from 3:00 - 4:00 pm (Eastern). Timothy J. Shea, Jr. of Sterne Kessler will moderate a panel including Jennifer L. Fox of Brinks Hofer Gilson & Lione and Dr. Denise M. Kettelberger of Faegre Baker Daniels. The panel will discuss the practical and legal implications of the proposed guidance documents issued by the FDA in February, and will consider strategies for companies seeking to market biosimilar products and for brand companies seeking to maintain market share in the face of biosimilar competition. Among the topics to be covered are:
• The scope and applicability of the proposed guidelines: What they do and do not cover;
• The FDA's stepwise approach to demonstrating biosimilarity;
• Which scientific considerations the FDA considers most important in evaluating biosimilarity;
• The extent and nature of clinical trials that will likely be required for approval;
• How changes in structure, formulation and manufacturing process will impact the review process; and
The interplay between the approval process and patent strategies.
A Q&A will follow the presentation and last for up to 30 minutes.
The registration fee is $125 per caller and $50 each additional person on the same line who desires continuing education credit. Those interested in registering for the telebriefing, can do so here.
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