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.
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.