Sandoz, a company owned by Swiss srug maker Novartis AG (NVS), said that the U.S. Food and Drug Administration or FDA has accepted its Biologics License Application for its proposed biosimilar to Amgen Inc.'s (AMGN) U.S.-licensed Neulasta or pegfilgrastim - a recombinant human granulocyte colony-stimulating factor or G-CSF.
Sandoz is seeking approval for the same indication as the reference product. Pegfilgrastim is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in patients with cancer (non-
myeloid) who receive chemotherapy that can cause fever and a low blood cell count, known as febrile neutropenia.
In the U.S., the incidence of febrile neutropenia is estimated to be more than 60,000 a year, accounting for nearly eight cases per 1,000 cancer patients. About 1.6 million people per year in the U.S. develop non-myeloid cancer.
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