Supreme Court Jumps Into Biosimilars Battle Over Launch Notification, Patent Dance
Following advice of Solicitor General, high court grants both Sandoz and Amgen Zarxio petitions challenging Federal Circuit’s interpretation of the biosimilars statute.
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Government urges Supreme Court to take up Sandoz’s Zarxio petition challenging Federal Circuit’s interpretation of the biosimilars statue; says it should also review Amgen’s challenge of ruling on patent dance.
Apotex wants Supreme Court to say that firm doesn't have to wait until FDA licensure of its pegfilgrastim and filgrastim biosimilars to provide Amgen 180-day notice of commercial marketing; Solicitor General has yet to weigh in on similar Sandoz petition.
Sandoz says it will launch Zarxio Sept. 2 as Federal Circuit rules 180-day notice of launch to Amgen must follow FDA approval.