On January 13, 2017, in Sandoz v. Amgen, the United States Supreme Court granted Sandoz’s petition for writ of certiorari to review the Biologics Price Competition and Innovation Act’s 180-day commercial marketing notice. One of the issues is whether a manufacturer of biosimilar pharmaceuticals must always wait until obtaining FDA approval of its abbreviated Biologics License Application before providing the 180-day marketing notice to the reference product sponsor. Oral argument is expected this spring.
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