FDA approves Teva cancer treatment biosimilar

Tbo-filgrastim is a biosimilar of Amgen's biologic drug Neupogen.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has obtained US Food and Drug Administration (FDA) approval tbo-filgrastim, a biological drug for the treatment of severe neutropenia (a reduction in white blood cells. in patients receiving chemotherapy for certain types of cancer. Tbo-filgrastim is a biosimilar (or copy) of Amgen Inc.'s (Nasdaq: AMGN) biologic drug Neupogen.

Tbo-filgrastim is a short-acting recombinant form of granulocyte colony-stimulating factor (G-CSF) to stimulate the bone marrow to produce white bloods cells to reduce the duration of severe neutropenia, which can make patients more susceptible to potentially life-threatening bacterial infections.

Teva already markets filgrastim in Europe under the trade name Tevagrastim, and plans to begin marketing in the US by November 2013, under the terms of a settlement reached with Amgen.

Teva chief scientific officer and global R&D president Dr. Michael Hayden said, "The approval of tbo-filgrastim demonstrates Teva's strong commitment to providing patients with new treatment options. It expands upon Teva's existing oncology portfolio with the addition of the first biologic and supportive care agent for oncology patients."

Published by Globes [online], Israel business news - www.globes-online.com - on August 30, 2012

© Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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