Biosimilars Regulation - Webinar Recording/Transcript

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Biosimilars Regulation: Latest Regulatory, Compliance & Approval Developments

The FDA is taking steps to more efficiently manage review and licensure pathways to facilitate biosimilar competition. These steps include:

  1. Modernizing policies governing the development of biosimilars to make it more efficient
  2. Educating clinicians, payors and patients about biosimilar products and the rigorous evaluation they must go through
  3. Modernizing regulatory policies to accommodate new scientific tools that better enable comparison between biosimilars and reference products that may reduce the need for clinical studies

In the last two months of 2018 the FDA approved three new biosimilar products. And, in December the FDA released three new guidances and a proposed rule concerning biosimilars.

  • Guidances:
    • Questions and Answers on Biosimilar Development and the BPCI Act  (Dec. 2018)
    • New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) (Dec. 2018)
    • Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009. (Dec. 2018) 
  • Proposed rule:
    • Definition of the Term “Biological Product” (Dec. 2018)

Nicholas Mitrokostas, partner in the Boston office of Goodwin Procter LLP and Daniel Orr, partner in the Washington, DC office of Womble Bond Dickinson LLP, will provide an overview of the FDA’s current review process, approval standards, and related issues confronting sponsors of reference biologics and biosimilars. Over the course of 90-minutes they’ll discuss:

  • Common problems concerning reference product exclusivity
  • How FDA currently reviews and decides whether to approve a biosimilar application
  • Regulatory and IP considerations and implications of seeking a carve-out of therapeutic indications in the aBLA product label
  • Considerations and implications of using foreign approved products in clinical studies supporting approval of an aBLA, or running clinical trials in foreign countries
  • Insider insight into FDA’s recently proposed rule and recent guidances

This presentation will help you understand current regulatory issues and problems confronting manufacturers of both reference biologics and biosimilars and the relevant intellectual property considerations that could impact regulatory strategy.

  • Executive suite
  • Strategic planners
  • Regulatory affairs
  • R&D
  • Marketing/sales
  • Legal counsel

Meet Your Presenters

Nicholas Mitrokostas is a Partner in the Boston office of Goodwin Procter LLP.  He has extensive trial and PTAB experience representing clients in the pharmaceutical and biotechnology industries in patent and antitrust litigation and counseling those clients with regard to their intellectual property and regulatory strategies.  He has a wide-ranging pharmaceutical practice representing both innovator and challenger entities, including filers of 501(b)(1), 505(b)(2), 505(j) and aBLAs. He is the lead editor of the firm’s Biosimilars Reference Guide and the biosimilars blog,, which provides resources, information and analysis on biologics, biosimilars and the Biologics Price Competition and Innovation Act (BPCIA).

Daniel Orr is a Partner in the Washington, DC office of Womble Bond Dickinson LLP and represents originator biopharmaceutical clients in FDA regulatory matters.  He previously served as a Regulatory Counsel with the U.S. Food & Drug Administration where he advised the agency concerning a portfolio of products with combined annual sales of more than $37 billion, including review and approval of three biosimilars. While at the FDA, Dan chaired the agency’s working group for the proposed rule “Definition of the Term ‘Biological Product” as well as serving on the agency’s Exclusivity Board for drugs and biologics.