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Teva Receives EU Marketing Authorization for G-CSF Biosimilar

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By Donald Zuhn -- Last week, Teva Pharmaceutical Industries Ltd. announced that the European Commission's Directorate General for Enterprise and Industry has granted the company a marketing authorization for its human granulocyte colony stimulating factor (G-CSF) product. Teva had earlier received a favorable opinion for its G-CSF product from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA). According to Teva's release, the company's G-CSF product, which will be marketed in Europe under the brand name TevaGrastim® beginning in 2009, is the first G-CSF biosimilar to receive a marketing authorization in the EU....

Full post as published by Patent Docs on September 25, 2008 (boomark / email).