Biosimilars Industry Loses First Battle as Supreme Court Refuses to Hear Amgen v. Apotex

The Supreme Court today refused to hear arguments in Amgen v. Apotex, in which Apotex argues that it should not be required to wait six months after the FDA approves its biosimilar before giving notice to brand-name manufacturer Amgen about its marketing plans, as Big Molecule Watch reports. However there’s another case—Sandoz v. Amgen—in which the six-month wait is also the point of contention. Sandoz still has some life.


The Solicitor General last week argued that Sandoz shouldn’t have to wait the six months either. Much depends on how the Supreme Court interprets the Biologics Price Competition and Innovation Act.


Source: Big Molecule Watch