title: The emerging role of biosimilar epoetins in nephrology in the United States.
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.
authors.affiliation: Division of Kidney Diseases and Hypertension, Department of Medicine, North Shore University Hospital and Long Island Jewish Medical Center, Hofstra North Shore-Long Island Jewish School of Medicine, Great Neck, NY. Electronic address: sfishbane@nshs.edu.
authors.forename: Steven
authors.initials: S
authors.lastname: Fishbane
authors.affiliation: Division of Kidney Diseases and Hypertension, Department of Medicine, North Shore University Hospital and Long Island Jewish Medical Center, Hofstra North Shore-Long Island Jewish School of Medicine, Great Neck, NY.
authors.forename: Hitesh H
authors.initials: HH
authors.lastname: Shah
mesh_terms: D000740:Anemia / Q000188:drug therapy / Q000209:etiology; D059451:Biosimilar Pharmaceuticals / Q000191:economics / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000627:therapeutic use*; D017048:Health Care Costs; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D009398:Nephrology / Q000639:trends*; D011994:Recombinant Proteins / Q000627:therapeutic use; D051436:Renal Insufficiency, Chronic / Q000150:complications; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D059451:Biosimilar Pharmaceuticals; D006397:Hematinics; D011994:Recombinant Proteins; C530192:epoetin zeta; D004921:Erythropoietin; D000068817:Epoetin Alfa
keywords: Biologic; Retacrit; anemia; bioequivalent drug; biosimilar; chronic kidney disease (CKD); economics; epoetin; epoetin alfa; epoetin zeta; erythropoiesis-stimulating agent (ESA); recombinant human erythropoietin (rHuEPO); safety