The US Food and Drug Administration has approved Teva Pharmaceutical Industries' version of Amgen's severe neutropenia therapy Neupogen.
The agency has backed tbo-filgrastim, which Teva says is the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the USA in more than 10 years. It is a copy of Neupogen (filgrastim), which the firm already sells in Europe as Tevagrastim and the Israeli firm noted that the drug was filed in the USA as a Biologics License Application "since a biosimilar approval pathway had not been established at the time of submission".
Teva will market tbo-filgrastim as early as November 2013, in accordance with the settlement reached with Amgen. It is intended for use in adults who have cancers other than blood or bone marrow cancers (ie non-myeloid malignancies) and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone marrow.
Tbo-filgrastim was evaluated in a clinical study of 348 adults with advanced breast cancer receiving treatment with doxorubicin and docetaxel. Its safety was analysed in three trials composed of 680 adults with breast cancer, lung cancer or non-Hodgkin’s lymphoma who received high-dose chemotherapy that reduces bone marrow cells.