Success Strategies for Biosimilars Approval - Webinar CD/Transcript

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Success Strategies for Biosimilars Approval: A Roadmap to the 351(k) Application Process

FDAnews is offering the combined knowledge and expertise of two leading intellectual property attorneys from the international law firm Duane Morris in the webinar CD and transcript Success Strategies for Biosimilars Approval: A Roadmap to the 351(k) Application Process.

Firm partner Kevin Nelson and Associate Dr. Patrick Gallagher will show you how to use the FDA’s guidance and prior decisions to greatly improve your chances of getting your 351(k) biosimilar applications approved — the first time.

They'll give you candid "what to do — and how to do it" advice, such as identifying the supporting clinical data you MUST include in your filings to gain approval quickly.  And the right way to apply the FDA’s latest recommendations for demonstrating that a proposed product is “highly similar” to a reference.

They'll also explain details you must understand about 4 critical topics from the recent FDA guidances:

  • How to establish a step-wise approach to product development — the way the FDA prefers
  • The agency's “totality of evidence” methodology for assessing
    351(k) applications
  • Using foreign reference products and the need for bridge studies
  • How analytics should be designed for pharmacokinetics and pharmacodynamics


In just 90 minutes, you'll increase your specific knowledge of unclear key areas of the application and approval process that you need to know to get on the fast track to approval:

  • Understanding the application pathway, including the statutory requirements for an approvable application
  • How the FDA’s thinking on the clinical requirements for showing biosimilarity has evolved with the 2015 guidance
  • Key takeaways from FDA’s latest guidances and FAQs
  • 7 'must-do' steps (all based on the new guidances) for preparing your application
  • How to successfully work with the FDA’s Biological Product Development Program (BPDP)

Order Strategies for Biosimilars Approval. You'll learn how to minimize the time it takes to win approval — and in doing so, maximize your company’s long-term revenue generating potential.

  • Clinical project specialists
  • Product lifecycle specialists
  • Pharmacokineticists/clinical pharmacologists
  • Medical affairs
  • Clinical data management and statistics personnel
  • R&D staff
  • Regulatory affairs professionals
  • Submission and approval specialists
  • Executive management
  • IP/general/corporate counsel
  • Consultants/service providers

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, he has represented generics companies exclusively in Hatch-Waxman litigation and related matters. Mr. Nelson has been lead trial counsel and has argued before the Court of Appeals for the Federal Circuit.

Dr. Patrick Gallagher is an associate in the Intellectual Property Practice Group of Duane Morris.  He has been involved in all aspects of Hatch-Waxman practice, including advising on Abbreviated New Drug Application filings, development of noninfringement 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.