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news.Teva Pharmaceutical Industries has announced that the European Commission's Directorate General for Enterprise and Industry has granted Teva a marketing authorization for its human granulocyte colony stimulating factor product.
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This marketing authorization follows the positive opinion issued by the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Evaluation Agency.
Teva’s product is said to be the first biosimilar granulocyte colony stimulating factor (G-CSF) to receive a marketing authorization in the EU and will be marketed under the brand name TevaGrastim. Teva will progressively begin marketing the product throughout Europe in 2009.
G-CSF, mainly indicated for the treatment of chemotherapy-induced neutropenia, was developed by Teva in collaboration with a partner.
Gerard Odijk, president and CEO of Teva Europe, said: “Our accomplishment – receiving the first marketing authorization in the EU for a biosimilar G-CSF product – demonstrates the strength of Teva’s biotechnology R&D capabilities and our commitment to bringing high quality and affordable biopharmaceutical products to the market.”