TevaGrastim filgrastim regulatory update

FDA approved a BLA from Teva for tbo-filgrastim (XM02) to treat severe neutropenia in patients with non-myelogenous malignancies receiving chemotherapy. The human granulocyte colony-stimulating factor (G-CSF) was approved under section 351(a) of the Public Health Service Act and therefore is not considered a biosimilar of Neupogen filgrastim, a granulocyte-colony stimulating factor (G-CSF) marketed by Amgen Inc. (NASDAQ:AMGN, Thousand Oaks, Calif.). FDA said that it will only make a determination on biosimilarity or interchangeability for a product submitted under the new 351(k) pathway, which was signed into law in 2010 as part of the Patient Protection and Affordability Act. Teva said the biosimilar pathway had not been established at the time of submission.

Tbo-filgrastim is subject to a 2011 patent litigation settlement with Amgen in which Teva admitted it infringed 2 patents covering Neupogen. Amgen noted in a statement that under the settlement, "Teva is prohibited by court order from marketing this product in the U.S. prior to Nov. 10, 2013" (see BioCentury, July 18, 2011). ...