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Tbo-Filgrastim: A Review in Neutropenic Conditions

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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.

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Acknowledgments

During the peer review process, the manufacturer of tbo-filgrastim was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Hannah A. Blair & Lesley J. Scott

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  1. Hannah A. Blair
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  2. Lesley J. Scott
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Correspondence to Hannah A. Blair.

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The preparation of this review was not supported by any external funding.

Conflict of interest

Hannah Blair and Lesley Scott are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: C. L. Bennett, South Carolina College of Pharmacy, Columbia, SC, USA; P. Tsirigotis, ATTIKO General Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.

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Blair, H.A., Scott, L.J. Tbo-Filgrastim: A Review in Neutropenic Conditions. BioDrugs 30, 153–160 (2016). https://doi.org/10.1007/s40259-016-0172-7

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