Biosimilars: Emerging Legal Challenges

Navigating FDA's Pathway to Approval, Patent Issues, and the Exclusivity Period

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

Conducted on Tuesday, December 6, 2011

Recorded event now available

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Course Materials

This CLE course will provide IP attorneys with a review of the complex standards of the FDA's Biosimilar Approval Pathway and address patent and exclusivity concerns around the development and marketing of biosimilars including information exchanges, infringement issues, and sameness and interchangeability questions.


Interest in biosimilars, new versions of existing innovator biopharmaceuticals whose patents have expired, is growing rapidly. Within a few years, more than half of newly approved medicines will be biopharmaceuticals—both innovator and biosimilar versions—according to estimates.

Healthcare reform set the stage for the FDA to approve biosimilars. To ensure safety and efficacy, the FDA created a daunting Biosimilar Approval Pathway. Counsel must develop new approaches to ensure a client’s research, development and production of biosimilars meets these high standards.

Patents and exclusivity periods present challenges in the development and marketing of biosimilars. Counsel must address these challenges by assessing the benefits and risks of patent exchange procedures, handling infringement issues, and utilizing the exclusivity period to a client’s advantage.

Listen as our authoritative panel of FDA regulatory and IP attorneys outlines the challenges of the Approval Pathway, discusses the complexities of exclusivity and how to leverage it, and provides information on key issues in biopharmaceutical patent issues.



  1. FDA’s regulation of biosimilars
    1. The Approval Pathway
    2. Definitions and problems of highly similar and interchangeability
    3. 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. 12-year exclusivity
    1. Definition of exclusivity
    2. Criteria for exclusivity


The panel will review these and other key questions:

  • 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?

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


Anthony J. Fitzpatrick
Anthony J. Fitzpatrick

Duane Morris

He co-chairs the firm's Intellectual Property Litigation Practice. He has litigated matters involving diverse...  |  Read More

Daniel A. Kracov
Daniel A. Kracov

Arnold & Porter

He heads the firm's FDA and Healthcare Practice and assists clients in negotiating the challenges relating to the...  |  Read More

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