Amgen, Inc.’s (AMGN) Neupogen could face competition in the near future from generic player, Teva Pharmaceutical Industries Ltd. (TEVA). Teva recently submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for XM02, a granulocyte colony-stimulating factor (G-CSF). Potential approval in 2010 could lead to the product launch in late 2010/early 2011.
 
Teva is looking to get the product approved for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.
 
XM02 is similar to Amgen’s Neupogen and will compete directly with Neupogen once launched. XM02 is already approved in the European Union where a biosimilars pathway exists. It is available in several markets in the EU under the name TevaGrastim – additional launches across the EU are expected going forward.
 
As a biosimilar pathway is yet to be approved in the U.S., Teva is looking to position XM02 as a new biotech medicine. The company’s BLA is based on results from a clinical program consisting of five studies with more than 680 patients.
 
The launch of XM02 in the U.S. would have a negative impact on Amgen’s top-line. Amgen’s granulocyte colony-stimulating factor (G-CSF) franchise, which consists of Neupogen/Neulasta, contributed 31% to revenues in 2008.
 
Neutropenia is a hematological disorder characterized by an abnormally low number of neutrophils, the most important type of white blood cell in the blood. Neutrophils usually make up 50-70% of circulating white blood cells and help fight against infections by destroying bacteria in the blood. Neutropenia may be caused by cancer or other diseases that damage bone marrow. It may also be caused by drugs that destroy neutrophils or damage bone marrow such as chemotherapy.
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