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.

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Biosimilar sponsors have a better shot at getting the US Supreme Court to decide whether they must wait until after FDA approval to provide 180-day notice of intent to launch their products now that they have the backing of the Solicitor General.

On Dec. 7, Acting Solicitor General Ian Gershengorn submitted a brief encouraging the court to grant Sandoz...

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