FDA's New Clinical Biosimilars Guidance

FDA’s New Clinical Biosimilars Guidance - Webinar CD/Transcript

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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.

  • Drug companies
  • Biotech companies
  • Contract research organizations
  • Testing laboratories           

Meet Your Presenters
Kevin Nelson is a partner in the Intellectual Property Practice Group of the international law firm, Duane Morris LLP.  For 14 years, Mr. Nelson has represented generic companies exclusively in Hatch-Waxman litigation and related matters, and has been lead trial counsel and has argued before the Court of Appeals for the Federal Circuit. 

Mr. Nelson has also assisted companies in the preparation of Abbreviated New Drug applications, formulation of design-around and invalidity strategies, the preparation of notice letters, and has represented companies before the United States Food and Drug Administration.  He has also advised clients regarding the filing of biosimilars applications, and has represented companies in trademark litigation and oppositions.

Dr. Patrick Gallagher is an associate in the Intellectual Property Practice Group of Duane Morris.  Dr. Gallagher has been involved in all aspects of Hatch-Waxman practice, including advising on Abbreviated New Drug Application filings, development of non-infringement and invalidity arguments for FDA-required notice letters, and in every phase of litigation through trial and appeal to the Federal Circuit Court of Appeals.

Dr. Gallagher also assists with advising agricultural, chemical and biotechnology companies with regulatory and intellectual property matters, including prevention and resolution of disputes and best strategies for protection of intellectual property.