FDA approves Teva's tbo-filgrastim

FDA approved a BLA late Wednesday from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) for tbo-filgrastim to treat severe neutropenia in patients with non-myelogenous malignancies receiving chemotherapy. FDA told BioCentury the product 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). FDA added 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.

tbo-filgrastim is subject to a 2011 patent litigation settlement with Amgen in which Teva admitted it infringed two patents covering Neupogen. In response to Wednesday's approval, Amgen said in a statement that "Teva is prohibited by court order from marketing this product in the U.S. prior to Nov. 10, 2013." Teva could not be reached for comment (see BioCentury Extra, July 15, 2011). ...