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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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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.

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