Neupogen Claim’s Orphan Protection May Keep Zarxio At Bay

FDA approval of Amgen’s granulocyte colony-stimulating factor for treatment of acute radiation syndrome carries seven years of orphan product exclusivity, which may keep the indication off the label of Sandoz’s biosimilar.

Orphan drug protection attached to a new claim for Amgen Inc.’s Neupogen (filgrastim) may preclude Sandoz Inc. from adding the same indication to labeling for its biosimilar Zarxio (filgrastim-sndz) in the near future.

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