Teva files BLA for XM02 with FDA for chemotherapy-induced neutropenia; a challenge to Amgen's Neupogen?

Israel's Teva Pharmaceutical Industries, better known as a global leader in the generic drug sector, has submitted a Biologics License Application with the US Food and Drug Administration for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.

XM02 was principally developed as a similar biological medicinal product to Neupogen, US biotechnology major Amgen's trade mark for filgrastim (G-CSF). In September 2008, XM02 received marketing authorization in the European Union where, unlike the USA, a biosimilars pathway exists. XM02 was launched in several EU markets under the trade name TevaGrastim and will be launched in additional EU markets over time.

Teva's BLA submission is based on results from a clinical program consisting of five studies with more than 680 patients. The key study, conducted in breast cancer patients, was a three-arm study of XM02, Neupogen or placebo in the first cycle of chemotherapy. Two additional clinical trials evaluating safety and efficacy were conducted in lung cancer and non-Hodgkin's lymphoma patients, which compared XM02 and Neupogen during the first cycle of chemotherapy. These studies demonstrated the efficacy of XM02 with regard to the duration of severe neutropenia, incidence of febrile neutropenia and measure of absolute neutrophil count change over time, which now needs to be reviewed by the US Food and Drug Administration.

Meantime, Amgen, which so far has not faced any generic competition for its drug in the USA, must wait and see what the FDA decides in terms of clearing a biosimilar for marketing. Global sales of Neupogen and a related medicine Neulasta were $1.21 billion in the third quarter of this year.