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news.The FDA has accepted for filing Teva Pharmaceutical Industries’ (Teva) Biologics License Application (BLA) for XM02. Teva's BLA was submitted to the FDA on November 30, 2009. The proposed trade name for XM02 is Neutroval.
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XM02 is a granulocyte colony-stimulating factor (G-CSF) for reducing the duration of severe neutropenia and the incidence of febrile neutropenia, in patients treated with established myelosuppressive chemotherapy for cancer.
The company said that XM02 was principally developed as a similar biological medicinal product to Neupogen, the trademark for filgrastim (G-CSF).
William Marth, president and CEO of Teva North America, said: “Our G-CSF product was the first G-CSF biosimilar product approved in Europe and we look forward to working closely with the FDA to bring this important treatment option to the US.”
Reportedly, in September 2008, XM02 received marketing authorisation in the EU, where a biosimilars pathway exists. XM02 was launched in several EU markets under the trade name, TevaGrastim, and is expected to be launched in additional EU markets over time.