2010 US Sales: $3.3 billion
Epogen is used to treat patients with a lower-than-normal number of red blood cells (anemia) caused by chronic kidney failure. Epogen stimulates the bone marrow to make more red blood cells and lessens the need for red blood cell transfusion.
Amgen has an exclusive license to manufacture and market Epogen in the U.S. under an agreement with K.A., Kirin-Amgen, Inc.
The drug first entered the U.S. market in 1989. Epogen falls under the category of biologic drugs, created by a biological process rather than a chemical one. At this point there are no legal regulatory provisions for generic versions of these drugs, which are deemed more complicated.
However, one wildcard is the possibility of the introduction of the Quality Improvement Program—a bundled payment system in dialysis—which, if approved by the Centers for Medicare & Medicaid Services, will decrease dose utilization, and therefore the sales of Epogen beginning in 2012.