Reactions to Eprex's adverse reactions

Monitoring drug safety with registries: useful components of postmarketing pharmacovigilance systems

“…A manufacturing change that replaced human serum albumin with polysorbate 80 and glycine in the formulation of Eprex (epoetin alphada medication licensed for use in patients with chronic renal failure) was reported to be associated with an increased incidence of pure red cell aplasia (PRCA): an extremely rare adverse outcome undetected by premarketing studies [8]. Whereas findings from spontaneous reports were used to estimate the incidence of PRCA in patients receiving Eprex, the need to prospectively study the rate of PRCA in chronic renal failure patients treated with erythropoiesis-stimulating agents, such as Eprex, has resulted in the establishment of the Prospective Immunogenicity Surveillance (PRIMS) registry [9]. Under the new EMA guidelines, registries, such as PRIMS may be useful ADR detection tools in situations where RCTs have not identified rare or latent ADRs, such as PRCA in this population.…”

EMEA Guidelines on Biosimilars and Their Clinical Implications

“…Although the precise reasons for increased immunogenicity of Eprex observed after 1998 is still debated, there is little doubt that it was triggered by the replacement of human serum albumin by polysorbate 80 [10,11] . Thus, immunogenicity of biosimilars to epoetin will be a true concern for all stakeholders.…”