Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) yesterday obtained marketing authorization from the European Commission Directorate General for Enterprise and Industry for TevaGrastim, a human granulocyte colony stimulating factor (G-CSF) product. It is a biosimilar product of Neupogen Filgrastim, a recombinant DNA treatment for chemotherapy-induced neutropenia (a blood disorder) made by Amgen Inc. (Nasdaq: AMGN).
The authorization is based on a positive opinion issued by the European Medicines Evaluation Agency (EMEA) science committee (CHMP). It is the first biosimilar G-CSF product to obtain EU marketing authorization. Teva will begin marketing the product throughout Europe in 2009.
According to IMS sales data, branded Neupogen Filgrastim had $1.3 billion in global and $300 million in EU sales in the year through June 2008.
Teva Europe president and CEO Gerard van Odijk 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. 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. Gaining this early experience is important for us to further enhance our capabilities in this field."
Teva currently markets a number of biopharmaceutical products including human growth hormone in the US (hGH), as well as interferon alpha 2b, G-CSF and hGH in other countries. The company's biogeneric pipeline includes other products that will be launched in the US and the EU, and other countries.
Teva rose 0.4% on Nasdaq yesterday to $45.96.
Published by Globes [online], Israel business news - www.globes-online.com - on September 17, 2008
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