FDA approves Teva biosimilar

Tbo-filgrastim approved under normal BLA pathway

JERUSALEM — The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

Teva announced the FDA approval of Tbo-filgrastim (XM02 filgrastim) for treating neutropenia, a condition in which the number of white blood cells is decreased, making patients more susceptible to life-threatening bacterial infections. The company sought approval using a biologics license application, or BLA, the same approval pathway used for novel biotech drugs because while the Patient Protection and Affordable Care Act created a regulatory approval pathway for biosimilars, the regulations have not yet been established.

Teva markets filgrastim in Europe under the trade name Tevagrastim, which is a biosimilar version of Amgen's Neupogen. Teva plans to market tbo-filgrastim starting in November 2013, under an agreement with Amgen.

"As a company dedicated to bringing needed medicines to patients, we are delighted with the approval of tbo-filgrastim, which offers physicians and their patients undergoing chemotherapy a new supportive care treatment option," Teva president of global research and development and chief scientific officer Michael Hayden. "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."

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