The Sandoz product is approved for the same range of indications as the reference product, Neupogen and offers patients comparable quality, safety and efficacy combined with greater cost-effectiveness.
The novel filgrastim needlestick protection device decreases the risks of injury and exposure to blood-born infection, thus contributing significantly to protecting health professionals, said Sandoz.
The European Commission approval followed a positive opinion issued in November 2008 by the European Medicines Agency’s Committee on Medicinal Products for Human Use, which provides scientific reviews of medicines for the commission.
Jeff George, CEO of Sandoz, said: As the pioneer of biosimilars and a company with a global reputation for offering high quality medicines at affordable prices to patients and payers worldwide, Sandoz is looking forward to providing this important new cost-effective option for oncology patients.
Filgrastim particularly helps patients receiving chemotherapy to increase their neutrophil counts, meaning they can better avoid the risk of the serious life threatening infections that so often force clinicians to change their optimal therapeutic chemotherapy regimen, dose or schedule.