Dosing Penalty after Switching from ESA Originator to Biosimilar: Matched Cohort Study in Stable Hemodialysis Patients

Background: In hemodialysis (HD), switch from ESA originator to biosimilar associates with dosing penalty (DP) of about 10% according to industry-driven studies. However, DP in daily clinical practice is ill-defined. Methods: From 12 non-profit centers, we selected consecutive ESA treated HD patients (2011-14) receiving stable i.v. ESA dose and not transfused in the previous 3 months. Patients switched from originators to biosimilars (BIO, n=153) were matched with those persisting with ESA originator (CON, n=153) to evaluate DP (difference of ESA dose between BIO and CON). Conclusions: In controlled conditions, switch from ESA originator to biosimilar requires doses higher than expected to maintain constant Hb. Besides economic issue, these data call for long-term studies to assess whether the lower efficacy of biosimilars poses a safety threat.