November 18, 2015
FDA accepts Sandoz regulatory submission for a biosimilar of cancer drug pegfilgrastim
The US Food and Drug Administration (FDA) has accepted Sandoz’s Biologics License Application (BLA) for its proposed biosimilar to Amgen’s US-licensed Neulasta (pegfilgrastim) – a recombinant human granulocyte colony-stimulating factor (G-CSF).