Sandoz, a Novartis company and the global leader in biosimilars, announced that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for its biosimilar to Amgen’s EU-licensed Neulasta®* (pegfilgrastim) – a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same indication as the reference product.
Pegfilgrastim is a prescription medicine used in cancer patients (except those with chronic myeloid leukemia and myelodysplastic syndromes) to help with some of the side effects of their treatment.
It reduces the duration of neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the incidence of febrile neutropenia (neutropenia with fever) that are a result of their chemotherapy treatment. The incidence of febrile neutropenia (FN) occurring with common chemotherapy regimens is 25 to 40% of treatment-naive patients.
