EC approves Nivestim for prevention of FN

March 07, 2016

"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.

SOURCE Hospira, Inc.