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Teva biosimilar delayed by FDA

The US Food and Drug Administration has requested additional information from Teva before acting on a Biologics License Application for Neutroval

The US Food and Drug Administration has requested additional information from Teva Pharmaceutical before it can act on the company's Biologics License Application (BLA) for Neutroval (granulocyte colony-stimulating factor), a therapy for neutropenia that could become the first generic biologic product to be sold in the US.

Neutroval is Teva's version of Amgen's Neupogen, which had sales of $901m in 2009.  Because there is not yet a regulatory pathway for generic biologics, Teva simply filed its application as though Neutroval were a new product, conducting its own clinical trials in support of approval. Amgen, which says it has US patent protection on its product until 2013, has filed a lawsuit attempting to block the Teva copy.

The FDA's Complete Response Letter requests that "several items" be added to Teva's BLA, which was originally filed in November, but does not request any additional premarketing clinical trials, Teva said. "Teva is reviewing and will work with the FDA to determine the appropriate next steps regarding this application," the company noted.

Neutropenia is a haematological disorder characterized by an abnormally low number of white blood cells known as neutrophils, which prevent infections by destroying bacteria in the blood. The condition is often caused by cancer and other diseases that damage bone marrow, as well as by chemotherapy drugs that destroy neutrophils or damage bone marrow.

1st October 2010

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