Table 5 List of currently approved granulocyte colony-stimulating factor biosimilars
From: What do oncologists need to know about biosimilar products?
Region | Active substance | Brand name (pharmaceutical company) | Indications in oncology | Approval date |
|---|---|---|---|---|
Europe | Filgrastim-XM02 | Ratiograstim (Ratiopharm) | Reduction in the duration of chemotherapy-induced neutropenia and the incidence of febrile neutropenia (except for chronic myeloid leukemia and myelodysplastic syndromes) Reduction in the duration of neutropenia caused by myeloablative therapy followed by bone marrow transplant Mobilization of peripheral blood progenitor cells | 15/09/2008 |
Tevagrastim (Teva) | 15/09/2008 | |||
Biograstim (ABZ-Pharma) | 15/09/2008 | |||
Filgrastim-EP2006 | Filgrastim Hexal (Hexal) | 06/02/2009 | ||
Zarzio (Sandoz) | 06/02/2009 | |||
Filgrastim-PLD108 | Nivestim (Hospira) | 08/06/2010 | ||
Apo-Filgrastim | Grastofil (Apotex) | 18/10/2013 | ||
Accofil (Accord) | 18/09/2014 | |||
United States | Filgrastim-EP2006 | Zarxio/(Sandoz) [Placeholder non-proprietary name: filgrastim-sndz] | Decrease in the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever Reduction in the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia Reduction in the duration of neutropenia and neutropenia related clinical sequelae (e.g., febrile neutropenia) in patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation Mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis | 06/03/2015 |
Australia | Filgrastim-PLD108 | Nivestim (Hospira) | Decrease in the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation; Reduction in duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukemia; Mobilization of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative or myelosuppressive therapy in patients with non-myeloid malignancies; Mobilization of peripheral blood progenitor cells in normal volunteers; for use in allogeneic peripheral blood progenitor cell transplantation; Treatment of patients receiving myeloablative chemotherapy, for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation | 16/09/2010 |
Filgrastim-XM02 | Tevagrastim (Aspen Pharmacare) | 29/08/2011 | ||
Filgrastim-EP2006 | Zarzio (Sandoz) | 07/05/2013 | ||
New Zealand | Filgrastim-PLD108 | Nivestim (Hospira) | Mobilization of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy and the mobilization of peripheral blood progenitor cells in normal donors [allogeneic peripheral blood progenitor cell (PBPC)] Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia and its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia | 24/05/2012 |
Filgrastim-EP2006 | Zarzio (Novartis) | 31/03/2014 | ||
Singapore | Filgrastim-PLD108 | Nivestim (Hospira) | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes) Reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia | 17/07/2012 |
Japan | Filgrastim | Filgrastim BS (Mochida/Fuji) | Treatment in neutropenia induced by anti-cancer chemotherapy | 21/11/2012 |
Filgrastim BS (Nippon Kayaku/Teva) | 28/02/2013 | |||
Filgrastim BS (Sandoz) | 24/03/2014 |