JERUSALEM Teva has filed a regulatory approval application with the Food and Drug Administration for a biosimilar for treating chemotherapy-induced neutropenia, the generic drug maker announced.
Teva said it filed a biologics license application with the FDA for XM02, a biosimilar of Amgen’s Neupogen (filgrastim). XM02 received approval in September 2008 for the European Union, where Teva markets it under the name TevaGrastim.
Chemotherapy-induced neutropenia is a blood disorder that results from an abnormally low number of neutrophils, a type of white blood cell that makes up 50% to 70% of white blood cells circulating in the body and is important in fighting bacteria. Because cancer and chemotherapy can damage the bone marrow and destroy neutrophils.
The application submission is based on results of five clinical studies with more than 680 patients. The main study, conducted on breast cancer patients, compared XM02 with Neupogen and placebo in the first cycle of chemotherapy. Two other trials were conducted on patients with lung cancer and non-Hodgkin’s lymphoma.
“We are pleased to complete the BLA submission for XM02, and as a result, mark a U.S. milestone for us as it is our first biologic product,” Teva North America president and CEO William Marth said. “Teva is dedicated to bringing high-quality and affordable biologics to our customers, including a portfolio of additional follow-on biologic drugs currently in research and development.”