![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » FDA Accepts Bid to License Neupogen Biosimilar
FDA Accepts Bid to License Neupogen Biosimilar
September 15, 2017
The FDA accepted for review a BLA application from Adello Biologics for a biosimilar to Amgen’s Neupogen (filgrastim).
A short acting granulocyte-colony stimulating factor, filgrastim increases production of white blood cells. It is used to treat neutropenia in cancer patients receiving myelosuppressive chemotherapy, as well as other conditions.
Adello supported its BLA submission with data from analytical, pre-clinical and clinical development studies.
Upcoming Events
-
21Oct