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The Emerging Role of Biosimilar Epoetins in Nephrology in the United States
American Journal of Kidney Diseases (04/15) Vol. 65, No. 4, P. 537; Fishbane, S.; Shah, H.H.
As lower-cost epoetins become available in the United States, it could significantly affect the treatment of anemia of chronic kidney disease, report researchers from North Shore University Hospital and Long Island Jewish Medical Center. A large amount of data collected on biosimilar epoetin, used in Europe since 2007, indicate that its efficacy and safety profiles are similar to those of originator epoetin alfa. Biologic drugs have an important role in the management of medical conditions, but biologics are costly and many patents will soon expire. Introducing competition to the marketplace can help to reduce costs, however. Europe established a specific regulatory pathway for approving biosimilars in 2005, and the U.S. Food and Drug Administration has developed a similar review pathway. Approval of biosimilars requires preclinical pharmacodynamic and toxicologic studies, studies to demonstrate bioequivalence and efficacy, and long-term monitoring of drug safety, the researchers note.
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