Biosimilar Sponsors Can Avoid Patent Dance, But Innovators Win Extra Exclusivity
This article was originally published in The Pink Sheet Daily
Executive Summary
Sandoz says it will launch Zarxio Sept. 2 as Federal Circuit rules 180-day notice of launch to Amgen must follow FDA approval.
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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.
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.
Biosimilar Launch Notification: Solicitor General Backs Pre-FDA Approval Notice
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.