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FDA’s New Clinical Biosimilars Guidance: Best Practices to Preparing a Successful 351(k) Application

Industry experts Kevin Nelson and Dr. Patrick Gallagher from Duane Morris LLP use examples from leading companies that are currently attempting to demonstrate biosimilarity.

In this session, you'll learn the specifics of the FDA’s newest recommendations for showing that a proposed product is “highly similar” to a reference product … gain fuller understanding of the impact of the just-released clinical guidance (and three 2012 guidances) on the original legislation … and get newly-updated ideas and strategies based on the recent guidance for how to file your upcoming 351(k) applications — and finally win approval.

You'll learn how, with the new guidance, the FDA’s thinking about clinical requirements for demonstrating biosimilarity is evolving. With the FDA’s New Clinical Biosimilars Guidance webinar CD and transcript you will gain:

• An understanding of the biosimilars application pathway, including the statutory requirements for an approvable application
• Insight into how the FDA’s thinking on the clinical requirements for showing biosimilarity has begun to evolve with the 2014 clinical guidance
• 7 tips for preparing your application in view of the new guidance
• Plan and talk with FDA early and often
• Address FDA’s key concepts with details
• Choose the correct assays and biomarkers
• Demonstrate “safety first”: a safety and immunogenicity showing is necessary
• Be creative in your proof: foreign data, simulation or predictive data
• But justify your creativity
• Plan evolution/flexibility: step-wise approach means your plan may evolve
• Implementing these 7 tips in preparing an approvable 351(k) application through the use of the Biological Product Development Program (BPDP)
• An understanding on how to use the inter partes review (IPR) process to tackle patent barriers and to lessen your patent litigation budget

You'll also be introduced to the 4 areas in the new guidance that are most likely to be of significant value to you in filing:

1. 3 key concepts that are most relevant in the FDA's review of applications: exposure and response assessment, evaluation of residual uncertainty, and analytical quality and similarity
2. 3 key assays that the FDA deems “particularity important”: ligand binding assays, concentration and activity assays, and PD assays
3. Use of foreign reference products and the need for bridge studies
4. How modeling and simulation tools can be useful for designing PK and/or PD studies

Hear from top thought leaders on this critical topic. Order FDA’s New Clinical Biosimilars Guidance: Best Practices to Preparing a Successful 351(k) Application webinar CD and transcript.