Tbo-Filgrastim: A Review in Neutropenic Conditions.

Abstract

Tbo-filgrastim (filgrastim XM02; Biograstim(®), Ratiograstim(®), Tevagrastim(®)) is approved in the EU as a biosimilar of filgrastim (Neupogen(®)) for use in all indications for which reference filgrastim is approved, including chemotherapy-induced neutropenia, neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation, mobilization of peripheral blood stem cells (PBSCs), severe chronic neutropenia, and neutropenia in HIV infection. Tbo-filgrastim (Granix(®)) is also approved as a biologic in the USA for neutropenia associated with chemotherapy. Tbo-filgrastim has demonstrated bioequivalence to reference filgrastim in terms of its pharmacokinetic and pharmacodynamic profiles. In phase III trials, tbo-filgrastim was equivalent to reference filgrastim in ameliorating severe neutropenia in patients receiving chemotherapy for breast cancer, lung cancer, or non-Hodgkin lymphoma. In addition, the efficacy of tbo-filgrastim for PBSC mobilization in the allogeneic and autologous settings has been demonstrated in several small studies. Tbo-filgrastim was generally well tolerated, with a similar safety profile to that of reference filgrastim. Most adverse events were of mild or moderate severity. Biosimilars such as tbo-filgrastim have the potential to reduce healthcare costs compared with those of reference filgrastim; this may provide patients with more cost-effective treatment options. Current evidence indicates that tbo-filgrastim is a useful alternative to reference filgrastim in patients requiring filgrastim therapy for various neutropenic conditions.