April 3, 2019
Sandoz resubmitting BLA for chemotherapy drug to the FDA
Sandoz is resubmitting its Biologics License Application for a proposed biosimilar pegfilgrastim to the US FDA
Pharmaceuticals, Biotechnology and Life Sciences
Tag: pegfilgrastim
October 27, 2017
Sandoz is seeking approval for use of its biosimilar to Amgen’s Neulasta, EMA to take a look at it
Novartis division Sandoz has gotten acceptance for its biosimilar to Amgen’s Neulasta by the European Medicines Agency (EMA) for regulatory…
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).