FDA accepts approval application for Teva's Neutroval

JERUSALEM The Food and Drug Administration has accepted a regulatory approval application from Teva Pharmaceutical Industries for a follow-on biologic, the generic drug maker announced Tuesday.

Teva submitted the application to the FDA on Nov. 30 for XM02, a biosimilar of Amgen’s Neupogen (filgrastim) that Teva plans to market under the name Neutroval.

The drug is used to treat chemotherapy patients experiencing severe neutropenia and febrile neutropenia, a reduction in the number of white blood cells that can result from cancer and chemotherapy.

Teva received approval in the European Union for the drug in September 2008, where it is marketed under the name TevaGrastim. The United States lacks a regulatory approval pathway for biosimilars, requiring Teva to seek regulatory approval using the same process that it would for a novel biologic. Currently, Sandoz’s Omnitrope (somatropin [rDNA origin]), a biosimilar of Pfizer’s growth-disorder treatment Genotropin, is the only biosimilar available in the United States, having received special FDA approval in 2006.

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