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FDA Approval Options for Follow-On Biologicals

  • 05.10.11
  • Paul A. Calvo & Timothy J. Shea, Jr.
  • World Intellectual Property Review

Parties seeking to market a follow-on biological product in the US traditionally have had two options for obtaining Food & Drug Administration approval of their product. With the passage of the Biologics Price Competition and Innovation Act last year, there is now a third option. Paul Calvo and Timothy Shea explain the key advantages and disadvantages of each.  Download the PDF for the full article.

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