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).