State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists

摘要: The European Medicines Agency (EMA), under a strictly regulated pathway, has approved several biosimilar products since 2005, including versions of the erythropoiesis-stimulating agent (ESA) epoetin alfa 2007. Subsequent to these approvals, use in management renal anemia grown steadily throughout Europe. With enactment US Biologics Price Competition and Innovation Act 2009, Food Drug Administration regulatory approval process for biosimilars was legalized. Thus, erythropoietin are expected be available prescription USA by mid-decade, presumably at price that is competitive with originator brand-name reference products. In this paper, we describe status ESAs, review clinical development erythropoietins Europe, summarize relevant efficacy safety information relation their provide background nephrologists as they appraise treatment options anemia. Key lessons learned from Europe (a) EMA-approved have comparable profiles product erythropoietin; (b) pharmacovigilance preapproval postapproval critical, especially regard immunogenicity vascular thromboembolic events; (c) strict requirements must guide pathway biosimilars; (d) high-quality manufacturing production processes established ensure quality availability will alternative effective, potentially more affordable, patients