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Title: Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies
Authors: Kearkiat Praditpornsilpa
Khajohn Tiranathanagul
Pawinee Kupatawintu
Saengsuree Jootar
Tanin Intragumtornchai
Kriang Tungsanga
Tanyarat Teerapornlertratt
Dusit Lumlertkul
Natavudh Townamchai
Paweena Susantitaphong
Pisut Katavetin
Talerngsak Kanjanabuch
Yingyos Avihingsanon
Somchai Eiam-Ong
Keywords: Medicine
Issue Date: 1-Jan-2011
Abstract: Recombinant human erythropoietin (r-HuEpo) has been used for the treatment of renal anemia. With the loss of its patent protection, there has been an upsurge of more affordable biosimilar agents, increasing patient access to treatment for these conditions. The complexity of the manufacturing process for these recombinant proteins, however, can result in altered properties that may significantly affect patient safety. As it is not known whether various r-HuEpo products can be safely interchanged, we studied 30 patients with chronic kidney disease treated by subcutaneous injection with biosimilar r-HuEpo and who developed a sudden loss of efficacy. Sera from 23 of these patients were positive for r-HuEpo-neutralizing antibodies, and their bone marrow biopsies indicated pure red-cell aplasia, indicating the loss of erythroblasts. Sera and bone marrow biopsies from the remaining seven patients were negative for anti-r-HuEpo antibodies and red-cell aplasia, respectively. The cause for r-HuEpo hyporesponsiveness was occult gastrointestinal bleeding. Thus, subcutaneous injection of biosimilar r-HuEpo can cause adverse immunological effects. A large, long-term, pharmacovigilance study is necessary to monitor and ensure patient safety for these agents. © 2011 International Society of Nephrology.
ISSN: 15231755
Appears in Collections:CMUL: Journal Articles

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