Clinical efficacy and safety of SB309, a biosimilar recombinant human erythropoietin, in the management of anemia

Alaa Bagalagel,^1,2 Abdulaziz Mohammed,^1,2 Karen MacDonald,³ Ivo Abraham<sup>1,3–5

1</sup>Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA; ²College of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; ³Matrix45, Tucson, AZ, USA; ⁴Department of Pharmacy Practice and Science, College of Pharmacy, ⁵Department of Family and Community Medicine, College of Medicine, University of Arizona, Tucson, AZ, USA

Abstract: In this second part of a series of three reviews of approved biosimilar erythropoietins, we review the evidence pertaining to the clinical efficacy and safety of SB309 relative to the originator product Eprex^®/Erypo^®. As in the first review, clinical efficacy is assessed with respect to the therapeutic equivalence of the biosimilar and originator product, while safety is evaluated in terms of immunogenicity, venous thromboembolism, and mortality. Seven studies in chronic renal failure and oncology populations are reviewed. In the renal setting, these include two randomized controlled trials on hemoglobin correction and maintenance in patients receiving long-term hemodialysis; open extension safety studies from both trials analyzed as a pooled database; a post hoc analysis on biosimilar and originator switching; a therapeutic equivalence study of subcutaneously administered SB309 and Eprex/Erypo; and a single-center experience study. In the cancer setting, one open-label non-controlled study is reported. Based on the available therapeutic equivalence and safety data, the clinical and safety outcomes of treatment with SB309 are likely to be similar to those of the originator product Eprex/Erypo. Both products can be considered interchangeable in the management of anemia for the approved indications. Patients transferred from reference product to biosimilar can be expected to show the same efficacy and safety outcomes. There is no evidence of the interchangeability of SB309 with other biosimilar or originator erythropoietins. In keeping with European Medicine Agency guidance regarding traceability, it is recommended that clinicians document the product by its commercial name, especially when switching patients from originator to biosimilar or vice versa.

Keywords: biosimilars, biosimilar pharmaceuticals, efficacy, safety, erythropoietin, recombinant proteins