Regulatory submission for Sandoz’ proposed biosimilar pegfilgrastim accepted by the FDA

Regulatory submission for Sandoz’ proposed biosimilar pegfilgrastim accepted by the FDA [1]

Publish Date:

Nov 18, 2015

Holzkirchen, November 18, 2015 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Neulasta® (pegfilgrastim)** – a recombinant human granulocyte colonystimulating factor (G-CSF).