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BioPharmaceutical United States Legal Issues

Neulasta Biosimilar: Smooth Patent Dance, Stumble On Launch Notification

This article was originally published in The Pink Sheet Daily

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Executive Summary

Amgen patent infringement suit follows information exchange with Apotex; Federal Circuit’s ruling on commercial notification to be tested.

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Biosimilar Barricade Breached: Amgen Manufacturing Patents Ruled Not Infringed

Apotex's Neulasta and Neupogen biosimilars do not infringe Amgen's patent, showing sponsors can get around innovator's manufacturing process patents.

Biosimilar Barricade Breached: Amgen Manufacturing Patents Ruled Not Infringed

Apotex's Neulasta and Neupogen biosimilars do not infringe Amgen's patent, showing sponsors can get around innovator's manufacturing process patents.

Biosimilar Litigation: Battles Continue Over Launch Notification, Access To FDA Info

A look at the status of suits involving Remicade, Neulasta, Epogen and Enbrel proposed biosimilars; Humira patents are being challenged in inter partes review proceedings rather than district court.

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