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Biopharmaceuticals Regulatory

 News Release - June 10, 2010

Nivestim(TM), a New Biosimilar Filgrastim, is Approved in Europe for the Prevention of Febrile Neutropenia Associated With Chemotherapy

Nivestim(TM), Hospira's filgrastim, has received approval from the European Commission (EC) for the prevention of febrile neutropenia (FN) and reduction in duration of chemotherapy-induced neutropenia (CIN)

Nivestim is a new filgrastim with a unique combination of administration, storage and safety features

Neutropenia is the most serious haematological toxicity that occurs as a result of cancer chemotherapy and can lead to chemotherapy dose reductions and/or dose delays compared with the prescribed schedule(1)

LEAMINGTON SPA, United Kingdom, June 10 (Healthcare Sales & Marketing Network) -- Hospira announced today that the EC has approved Nivestim™ (filgrastim) for the prevention of FN, the most serious haematological toxicity that occurs as a result of cancer chemotherapy(1). Nivestim now has marketing authorisation in all EU member states. Nivestim is expected to reduce the cost of neutropenia treatment.

Dr Cornelius Waller, Associate Professor of Internal Medicine at the Freiburg University Medical Center, Germany, said: "The approval of Nivestim offers tangible benefits to healthcare professionals and patients alike. Neutropenia that occurs as a result of cancer chemotherapy can result in patients being unable to complete their full course of chemotherapy. Nivestim provides healthcare professionals with a cost-effective, easy-to-use option to keep patients on track."

Nivestim is Hospira's second biosimilar. The company's biosimilar erythropoietin, Retacrit™, is currently available in 17 European countries, and Hospira is the first US-headquartered company to market biosimilar drugs in Europe. The company's biosimilar pipeline, one of the largest in the industry, also includes pegfilgrastim, a longer-acting version of filgrastim.

"As part of Hospira's continued commitment to expand its biosimilar portfolio, we are proud to announce that Nivestim has received licence approval from the EC," said Ron Squarer, chief commercial officer, Hospira. "Nivestim addresses unmet needs of patients and healthcare professionals through a unique combination of features that enhance convenience and safety, while reducing the cost of treatments."

Nivestim is a new filgrastim available in three presentations – 48 MU (480 mcg), 30 MU (300 mcg) and the unique 12 MU (120 mcg) 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. Each syringe has an integrated needle-safe device to facilitate safer administration and is individually blister-packed to reduce the risk of contamination and provide tamper-evidence.

In a large, randomised Phase lll study, Nivestim demonstrated comparable efficacy to Neupogen® in the prevention of FN, and was as well tolerated, with a similar adverse event profile.(2)

Notes to Editors:

About Hospira

Hospira is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Illinois, United States and has approximately 13,500 employees. The head office for Hospira in Europe, Middle East and Africa is in Leamington Spa, UK. Learn more at


1. Crawford J, Dale DC, Lyman GH. Chemotherapy-Induced Neutropenia: Risks, Consequences, and New Directions for Its Management. Cancer, 2004; 100(2): 228-37

2. 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.

Source: Hospira

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