Filgrastim Approved in EU to Prevent Febrile Neutropenia Linked With Chemotherapy

Yael Waknine

June 17, 2010

June 17, 2010 — The European Commission has approved a biosimilar formulation for filgrastim (Nivestim; Hospira, Inc; reference product: Neupogen; Amgen, Inc) to prevent febrile neutropenia and reduce the duration of chemotherapy-induced neutropenia. The approval is valid in all member states of the European Union.

Neutropenia is the most serious hematologic toxicity related to cancer chemotherapy and can lead to therapeutic dose reductions and/or delays.

"Neutropenia that occurs as a result of cancer chemotherapy can result in patients being unable to complete their full course of chemotherapy," said Cornelius Waller, MD, associate professor of internal medicine at the Freiburg University Medical Center, Germany, in a company news release. "Nivestim provides healthcare professionals with a cost-effective, easy-to-use option to keep patients on track."

Approval of the biosimilar formulation was based on phase 3 study data showing Nivestim has comparable quality, safety, and efficacy to Neupogen in the prevention of febrile neutropenia. Adverse events most commonly reported included bone, joint, and muscle pain; elevations in blood levels of uric acid and certain enzymes; leucocytosis; thrombocytopenia; anemia; headache; nose bleed; enlarged spleen; and nausea.

Filgrastim also is indicated to reduce the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation who are considered to be at increased risk for prolonged severe neutropenia.

As with Neupogen, the generic formulation of Nivestim will be available in prefilled syringes containing 48 MU (480 μg, 0.5 mL) and 30 MU (300 μg, 0.5 mL); a novel strength of 12 MU (120 μg, 0.2 mL) will also be marketed. Each syringe features an integrated needle-safe device to facilitate safe self-administration and is individually blister-packed to decrease the risk for contamination and to allow detection of tampering.

Filgrastim is Hospira's second follow-on biologic to be approved — the company's biosimilar epoetin zeta product (Retacrit; reference product: epoetin alfa, Eprex/Erypo; Janssen-Cilag [Johnson & Johnson]) is currently available in 17 European countries for the treatment of anemia.