Sandoz receives European Commission approval for biosimilar filgrastim

摘要

Sandoz has received final approval for its third biosimilar, filgrastim, paving the way for this important oncology medicine to be made available to patients across the European Union.Filgrastim is indicated for the treatment of neutropenia, a condition characterized by a lack of neu-trophils - one of the most common types of white blood cells - whose role is to fight infection in the body. Neutropenia is often associated with chemotherapy or bone marrow transplants, as well as advanced HIV infections. Filgrastim is a natural protein produced commercially by recombinant DNA technology, which stimulates production of white blood cells. 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 Sandoz filgrastim needlestick protection device decreases the risks of injury and exposure to blood-born infection, thus contributing significantly to protecting health professionals.