The US Food and Drug Administration (FDA) has decided not to approve Novartis’s application for a biosimilar of Amgen’s Neulasta, also known by the generic name pegfilgrastim.
The FDA issued a complete response letter for the pegfilgrastim biosimilar last month.
Novartis has not provided details about the agency’s decision or the contents of the letter, but the company said it is working with the FDA to answer its questions about the drug.
Novartis was seeking approval for its pegfilgrastim biosimilar for the same indication as Amgen’s Neulasta.
Neulasta is a leukocyte growth factor that is FDA-approved for the following indications:
- To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
- To increase survival in patients acutely exposed to myelosuppressive doses of radiation.
Neulasta is not FDA-approved for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
