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

Recording of a 90-minute premium CLE webinar with Q&A

Conducted on Wednesday, October 9, 2013

Recorded event now available

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Course Materials

This CLE course will provide a drill-down for IP counsel on the FDA's draft guidances and considerations raised in public meetings to navigate the complex standards of the FDA's Biosimilar Approval Pathway. The panel will also address the challenging issues concerning complying with the patent information exchanges required by the BPCIA, and discuss emerging legal challenges, including potential ethical considerations.


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sponsors must prepare to interact with the FDA on its current approach to biosimilars as expressed through a series of draft guidance documents (ver. 4 released in March 2013).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



  1. FDA regulation of biosimilars
    1. The new guidance
    2. The approval pathway
    3. Definitions and problems of "highly similar" and "interchangeability"
    4. Production issues and concerns of safety and efficacy
  2. Patent issues regarding the development and marketing of biosimilars
    1. The patent exchange procedures
    2. Disclosure of biosimilars application
    3. Infringement issues
  3. Exclusivity
    1. Definition of exclusivity
    2. Criteria for exclusivity
  4. Best practices for protecting the technology
    1. Patents
    2. Trade secrets


The panel will review these and other key questions:

  • How will the draft guidances 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 are the ethical and strategic challenges arising from the different rounds of litigation that may occur as a result of the statute?

Following the speaker presentations, you'll have an opportunity to get answers to your specific questions during the interactive Q&A.


Howard W. Levine
Howard W. Levine

Finnegan Henderson Farabow Garrett & Dunner

Mr. Levine has over 20 years of experience in patent litigation, primarily in the areas of biotechnology and...  |  Read More

Noonan, Kevin
Kevin E. Noonan, Ph.D.

McDonnell Boehnen Hulbert & Berghoff

Dr. Noonan's practice involves all aspects of patent prosecution, interferences, and litigation. He represents...  |  Read More

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