By Donald Zuhn --
Last week, Teva Pharmaceutical Industries Ltd. announced that the European Commission's Directorate General for Enterprise and Industry has granted the company a marketing authorization for its human granulocyte colony stimulating factor (G-CSF) product. Teva had earlier received a favorable opinion for its G-CSF product from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA).
According to Teva's release, the company's G-CSF product, which will be marketed in Europe under the brand name TevaGrastim® beginning in 2009, is the first G-CSF biosimilar to receive a marketing authorization in the EU. The EMEA website indicates that the Filgrastim biosimilars Filgrastim ratiopharm, Ratiograstim, and Biograstim all received favorable opinions from the CHMP.
Filgrastim is an immunostimulating medicinal product that regulates the production and release of functional neutrophils from the bone marrow. Teva's version of the drug has been indicated for the 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 leukaemia and myelodysplastic syndromes) and for the 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.
Teva noted that the brand product, Amgen's Neupogen® Filgrastim, had sales of approximately $300 million in the EU from July 1, 2007 to June 30, 2008.
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