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Abstract:
In this third paper of a series of three reviews on approved biosimilar erythropoietins, we review the evidence about the clinical efficacy and safety of XM01 (epoetin theta). XM01 was developed as a stand-alone product but is considered clinically as a biosimilar. As in the preceding reviews, clinical efficacy is assessed as a function of therapeutic equivalence of biosimilar versus reference product and, in the cancer setting, also superiority over placebo; while safety is evaluated in terms of immunogenicity, venous thromboembolism and mortality. Four studies on patients with chronic kidney disease and three studies on oncology patients are reviewed. In the renal setting, these include two randomized controlled trials on hemoglobin maintenance in hemodialysis and predialysis patients; as well as two open-label extension studies in these populations that also include Phase II patients. Studies in the cancer setting include three randomized controlled trials; in patients with solid tumors receiving platinum-based chemotherapy, in patients with either solid tumors or hematological malignancies receiving non-platinum based chemotherapy, and in patients with hematological malignancies undergoing antineoplastic therapy. Based on the available data, the clinical and safety outcomes of treatment with XM01 are likely to be similar to those of the comparator product NeoRecormon® and superior over placebo. Both XM01 and NeoRecormon® can be considered interchangeable in the management of anemia in 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 for the interchangeability of XM01 with other biosimilar or originator erythropoietins. In keeping with EMA guidance about traceability, it is recommended that clinicians document the product prescribed by its commercial name, especially when switching patients from originator to biosimilar or vice versa.