Teva Pharmaceutical Industries Ltd announced that the European Commission's Directorate General for Enterprise and Industry granted Teva a marketing authorization for its human granulocyte colony stimulating factor (G-CSF) product.
This marketing authorization follows the positive opinion issued by the CHMP, the scientific committee of the European Medicines Evaluation Agency (EMEA). Teva's product is the first biosimilar G-CSF to receive a marketing authorization in the European Union 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. The brand product, Neupogen Filgrastim had worldwide sales of approximately $1.3 billion and approximately $300 million in the EU for the twelve months that ended June 30, 2008, based on IMS sales data.
Gerard van Odijk, president and CEO of Teva Europe, said, "As the EU Commission defined the regulatory pathway for the approval of biosimilars in Europe, Teva drew on its extensive resources to develop this product, receive approval and bring it to the market. Gaining this early experience is important for us to further enhance our capabilities in this field."
Teva currently markets a portfolio of biopharmaceutical products including human growth hormone (hGH) in the United States, as well as interferon alpha 2b, G-CSF and hGH outside the United States. Teva's biogeneric pipeline includes many other products to be launched in the US and the EU, as well as in other markets.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company.