Sandoz, a Novartis company and the global leader in biosimilars,
announced that the European Medicines Agency (EMA) has accepted their
Marketing Authorisation 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.
Commenting
on today's milestone, Richard Francis, Division Head and CEO Sandoz
said, "Securing five major regulatory file acceptances in five months
demonstrates substantial progress on our long-term biosimilars
investment strategy. Further advancing our biosimilars pipeline is an
important priority for us this year and we'll continue to invest
significantly in bringing our pipeline to patients."
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 per cent of treatment-naive patients
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