Teva gets EU approval for G-CSF generic

Israel-headquartered Teva Pharmaceutical Industries says that the European Commission's Directorate General for Enterprise and Industry has granted a Marketing Authorization for the firm's human granulocyte colony stimulating factor (G-CSF) product.

This MA follows the positive opinion issued by the scientific committee of the European Medicines Agency (EMEA). Teva's product is the first biosimilar G-CSF to receive clearance in the European Union and will be marketed under the brand name TevaGrastim. and the drugmaker will progressively begin rolling the product out over Europe in 2009.

G-CSF, mainly indicated for the treatment of chemotherapy-induced neutropenia, was developed by Teva in collaboration with a partner. The brand product, Amgen's Neupogen (filgrastim), had worldwide sales of around $1.3 billion and about $300.0 million in the EU for the 12 months ended June 30, based on IMS sales data.