Hospira’s biosimilar filgrastim product Nivestim approved

Biosimilars/News | Posted 25/06/2010 post-comment0 Post your comment

On 10 June 2010, Hospira received approval from the European Commission for its biosimilar filgrastim product, Nivestim, for the prevention of febrile neutropenia and reduction in duration of chemotherapy-induced neutropenia.

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Filgrastim, a recombinant human granulocyte colony-stimulating factor (G-CSF), is the active ingredient of US biotechnology major Amgen’s Neupogen. It is a growth factor used to aid the recovery of bone marrow after chemotherapy treatment for cancer. Especially in patients with neutropenia (low white blood cell count in the blood).

Nivestim is available in three presentations: 480 mg, 300 mg and a unique 120 mg low weight presentation. All presentations are available in a pre-filled syringe, allowing patients to self-administer Nivestim at home, thus conserving valuable healthcare resources. In a large, randomised Phase lll study, Nivestim demonstrated comparable efficacy to Neupogen (Amgen) in the prevention of febrile neutropenia, and was as well tolerated, with a similar adverse event profile.

US-based generics manufacturer, Hospira, is one of the world leaders in specialty generic injectable pharmaceuticals, and expects the introduction of Nivestim in Europe to “enhance convenience and safety, while reducing the cost of treatments”.

Nivestim is Hospira's second biosimilar. The company’s biosimilar erythropoietin, Retacrit, is currently available in 17 European countries. The company's biosimilar pipeline, one of the largest in the industry, also includes pegfilgrastim, a longer-acting version of filgrastim.

References:

Hospira News Release, Nivestim(TM), a New Biosimilar Filgrastim, is Approved in Europe for the Prevention of Febrile Neutropenia Associated With Chemotherapy, June 10, 2010

Waller, CF et al. Biosimilar filgrastim is an effective primary prophylactic therapy for neutropenia in patients (pts) receiving doxorubicin and docetaxel (AT) for breast cancer (BC). Poster presentation at the joint ECCO 15 and 34th ESMO Multidisciplinary Congress: Abstract E15-1238, 2009.

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