International Urology and Nephrology (09/01/2015) Vol. 47, No. 9, P. 1529; Covic, A.; Abraham, I.

In this paper, researchers examine the status of originator and biosimilar erythropoiesis-stimulating agents (ESAs) and review the clinical development and regulatory approval of biosimilar erythropoietins in Europe. In addition, they summarize efficacy and safety information of biosimilar erythropoietins in relation to their reference products to provide a background for nephrologists in the United States as they consider biosimilar erythropoietins as treatment options for renal anemia. According to the authors, lessons learned from Europe include that European Medicines Agency-approved biosimilar erythropoietins have comparable efficacy and safety profiles to their reference product erythropoietin, pharmacovigilance preapproval and postapproval are critical, and high-quality manufacturing and production processes must be established to ensure quality biosimilar products. The researchers note that "the availability of biosimilar erythropoietins in the USA will provide nephrologists with alternative effective, and potentially more affordable, treatment options for patients with renal anemia."

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