Biosimilars Litigation in the United States: Amgen v. Sandoz

I  gave a talk  on biosimilars litigation in the US.  The June 1 program  was  sponsored by the Faculty of Law, University of Copenhagen, Denmark.  Slides from my presentation are available here.

A good part of the talk discussed the Amgen v. Sandoz case, which worked its way up to the United States Supreme Court.  The two questions before this Court were:

  • Is it mandatory for the biosimilars applicant (i.e., the generic company) to share application and information with the original developer of the biological product (i.e., the brand name company)
  • Can the 180-day notice of first commercial marketing by the biosimilars applicant to the reference product sponsor be given prior to FDA approval of the biosimilars application?

 July 9, Update: On June 12, the Supreme Court answered these questions (subject of a later post).  Yes, I am behind (an extended European trip can do that for you).