Lupin has announced that its first 351(k) biologics license application in the US, for its proposed biosimilar version of Neulasta (pegfilgrastim), has been accepted for filing by the US Food and Drug Administration.
Lupin’s Pegfilgrastim Biosimilar Accepted By US FDA
Neulasta Rival Faces A Crowded Market With Four Approved Competitors
Lupin’s first US biosimilar application, for a rival to Neulasta, has been accepted for filing by the FDA. If approved, the product would join an already crowded market for pegfilgrastim in the US.
