Supreme Court ruling gives biosimilar makers a boost
Biosimilar makers could get drugs to market more quickly following a recent ruling from the Supreme Court. In a unanimous opinion, the Supreme Court ruled that biosimilar drug developers won’t have to wait for FDA approval to give branded drugmakers a 180-day notice of commercial marketing.
Novartis’ Sandoz and Amgen, the two parties involved in the case, have conflicting interpretations of the Biologics Price Competition and Innovation Act (BPCIA), which expedited biosimilar regulatory approval. Amgen sued Sandoz in 2014, claiming they failed to follow the BPCIA when submitting its biosimilar Zarxio to the FDA.
