Cancer Treatment - Filgrastim-Alternative Nivestim Gets Approval

Hospira, Inc., the global leader in the production of generic injectable pharmaceuticals, which also boasts one of the broadest portfolios of generic acute-care and oncology injectables in the world, recently announced the approval of its biosimilar filgrastim product, Nivestim, for distribution in Australia, by the Therapeutic Goods Administration (TGA) of Australia. The TGA granted approval to Nivestim for several indications, which included the prevention of febrile neutropenia (FN) as well as the treatment of chemotherapy-induced neutropenia (CIN), which are serious hematological toxicities which generally occur as a side effect of chemotherapy.

Tim Oldham, the President of Hospira in the Asia Pacific region, issued the following statement following the granting of approval for Nivestim by the TGA: “Approval of Nivestim, the first biosimilar filgrastim in Australia, is another important milestone for Hospira as we build our global biosimilars portfolio. Nivestim will help reduce the cost of providing this lifesaving therapy across Australia, and includes a unique combination of administration, storage and safety features that will enhance safety for healthcare professionals and patients.”

The TGA granted this approval to Nivestim following a large, randomized Phase III study, in which Nivestim was found to be comparable to Neupogen, the Australian market leader for the treatment of neutropenia, in terms of effectiveness, patient tolerance as well as adverse event profiles.