The Emerging Role of Biosimilar Epoetins in Nephrology in the United States
Publication Date
2015
Journal Title
Am J Kidney Dis
Abstract
Biologic drugs, including epoetin, continue to play an important role in the management of medical conditions. However, biologics are costly and soon many of the patents on these drugs will expire, making way for non-brand name products (ie, biosimilars). It is only by introducing competition to the marketplace that costs will de-escalate. In Europe, a specific regulatory pathway for approving biosimilars has been in place since 2005. A similar review pathway in the United States has been developed by the US Food and Drug Administration. These guidelines for approving biosimilars are stringent, requiring preclinical pharmacodynamic and toxicologic studies, clinical studies to demonstrate bioequivalence and efficacy, and long-term postmarketing studies to monitor drug safety. Biosimilar epoetin has been used in Europe since 2007, and a wealth of data has been collected. These studies and reports indicate that the efficacy and safety profiles of biosimilar epoetin are similar to those of originator epoetin alfa. Biosimilars of epoetin alfa are expected to be among the first biosimilar agents to be approved for use in the United States. The availability of lower cost epoetins may have significant impact on the treatment of anemia of chronic kidney disease. (C) 2015 by the National Kidney Foundation, Inc.
Volume Number
65
Issue Number
4
Pages
537-542
Document Type
Article
EPub Date
2015/01/15
Status
Faculty
Facility
School of Medicine
Primary Department
Nephrology
PMID
DOI
10.1053/j.ajkd.2014.11.018