AMGN SPOKE PERSON AT FDA CHALLENGED FOR REPORT TO BE TRUE....
The healthcare community and dialysis patients alike had high hopes for Omontys, the first drug to challenge
Amgen’s monopoly rainmaker Epogen in treating anemia in dialysis patients. Epogen is an erythropoiesis-stimulating agent (ESA), a laboratory-synthesized version of erythropoietin, a human protein that stimulates the production of red blood cells in the bone marrow. Omontys binds to the same receptor in the human body but is otherwise dissimilar to Epogen.
In late 2009, Roche acknowledged its Micera ESA infringed five of Amgen’s patents for Epogen. The two companies executed a license agreement that will allow Roche to sell Micera in the US in mid-2014. Biosimilar forms of Epogen won’t reach the US market until Amgen’s latest patent expires in 2015.