Tag: Mark McCamish

November 18, 2015 Off

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).

October 2, 2015 Off

FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

By Dino Mustafić

Novartis company has announced 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 Enbrel (etanercept) – a tumor necrosis factor alpha (TNF-alpha) inhibitor.