Biosimilars: Navigating FDA’s Evolving Approval Pathway, Protecting Patents and Trade Secrets

October 9, 2013 | 1:00 p.m. ET | Strafford Webinar/Teleconference

This CLE webinar will provide a drill-down for IP counsel on the FDA’s 2013 draft guidance to navigate the complex standards of the FDA’s Biosimilar Approval Pathway. The panel will also address the most challenging issues around patent and exclusivity in developing, marketing and obtaining approval for biosimilars in and outside the U.S.


Attention to biosimilars, a biological product similar/interchangeable with another FDA-approved biologic, has increased since the Biologics Price Competition and Innovation Act (BPCI Act) first required the FDA to implement an “abbreviated” approval pathway for biosimilars. The market in biosimilars is forecast to be in the hundreds of billions with many top-selling pharmaceutical biologics scheduled to lose patent protection in the next several years.

With the U.S. falling behind Europe on biosimilar approvals, which will only escalate once the European Medicines Agency finalizes its new guidelines, this convergence of factors sets the stage for firms to launch competitive biosimilars in the next few years. Multinational companies can secure approvals that are currently available in other countries.

Counsel to potential U.S. biosimilar sponsors must prepare to interact with the FDA on its current approach to biosimilars as expressed through a series of draft guidance documents (ver. 4 released in March 2013).

IP practitioners must make their way through the current daunting FDA requirements on requesting, scheduling, conducting and documenting a formal meeting with the FDA under the latest draft guidelines for approving biosimilars. Attorneys must also act to protect trade secrets during FDA review of applications.

Listen as our authoritative panel of IP attorneys explains the FDA’s current approach toward approving and regulating biosimilars, outlines challenges that counsel will face, and offers practical approaches. The panel will also examine the complexities of exclusivity, offer best practices for protecting IP and trade secrets in the FDA process, and offer perspectives on patent and exclusivity in developing, marketing and preparing to obtain approval of biosimilars.


    FDA regulation of biosimilars

    • The new guidance
    • The approval pathway
    • Definitions and problems of “highly similar” and “interchangeability”
    • Production issues and concerns of safety and efficacy

    Patent issues regarding the development and marketing of biosimilars

    1. The patent exchange procedures
    2. Disclosure of biosimilars application
    3. Infringement issues


    1. Definition of exclusivity
    2. Criteria for exclusivity

    Best practices for protecting the technology

    1. Patents
    2. Trade secrets


The panel will review these and other key questions:

  • How will the latest draft guidance impact protection for biosimilars?
  • What are the FDA’s definitions for “highly similar” and “interchangeability”?
  • What are the market protection issues raised by patent exchange procedures for biopharmaceuticals?
  • What is the criteria for the 12-year exclusivity period?



  • Howard W. Levine, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
  • Kevin E. Noonan, Ph.D., Partner, McDonnell Boehnen Hulbert & Berghoff LLP, Chicago


Sponsored by: Strafford Publications, Inc.

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