BioCentury
ARTICLE | Company News

Teva withdraws balugrastim BLA

November 19, 2013 1:57 AM UTC

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said it withdrew a BLA for balugrastim, a long-acting recombinant human G-CSF fused to human albumin that had been under FDA review for neutropenia. The company, which submitted the BLA in December 2012, said it will work with FDA to design any additional studies that may be required. Teva said it is "assessing its options" for its long-acting G-CSF program, but could not be reached for details. Balugrastim is comparable to neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN).

Teva also announced launches for two other G-CSF products. In the U.S., the company launched Granix tbo-filgrastim, a short-acting recombinant form of G-CSF comparable to Amgen's neutropenia drug Neupogen filgrastim. In Germany, Teva launched Lonquex lipegfilgrastim, a glycol-pegylated recombinant human G-CSF comparable to Neulasta. Last month, Amgen disclosed on a conference call to discuss its 3Q13 earnings that Teva withdrew a BLA for Lonquex (see BioCentury Extra, Oct. 22). ...