Teva's Developed G-CSF Is The First Biosimilar To Receive A Positive Opinion From European Union Regulators, Europe

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 25 Feb 2008 - 3:00 PDT

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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced the receipt of a positive opinion from the CHMP, the scientific committee of the European Medicines Agency ("EMEA"), for its human granulocyte colony stimulating factor ("G-CSF") product. Teva's product is the first biosimilar G-CSF to receive a positive opinion in the European Union.

The European Commission is now expected to grant marketing authorization for this product, which will be marketed in the EU by Teva under the brand name TevaGrastim®.

G-CSF, mainly indicated for the treatment of chemotherapy-induced neutropenia, was developed by Teva in collaboration with a partner. The innovator product, Neupogen® Filgrastim, had annual sales of approximately $300 million in the EU for the twelve months ended September 30, 2007, based on IMS sales data.

Amir Elstein, Executive Vice President, Global Resources of Teva, stated today: "We are very pleased to receive the first positive opinion for a biosimilar G-CSF product in the EU and believe that it shows the strength of our biotechnology R&D capabilities. Our successful development of this product reflects our commitment to bringing high quality and affordable biopharmaceutical products to patients and payers. Coupled with our recent acquisition of CoGenesys, which significantly enhances our capabilities, our strong biogeneric pipeline reflects our determination to capture the considerable long-term prospects we believe the biogeneric market will offer."

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 commercialized in the US and the EU, as well as in other markets.

About Teva

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Europe.

Teva Pharmaceutical Industries Ltd.