Sandoz’ Neulasta Biosimilar Filing Joins Another Pending At FDA

The Novartis drug unit said the biosimilar pegfilgrastim application was accepted by FDA, positioning the 351(k) filing for action in mid-2016.

FDA's acceptance of Novartis AG’s biosimilar version of Amgen Inc.’s neutropenia mainstay Neulasta (pegfilgrastim) puts the company in the running to bring its second biosimilar to the US market.

Novartis' Sandoz Inc. generic drug unit revealed the acceptance of the filing on Nov. 18. Under the 10-month review...

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