Clinical efficacy and safety of Tevagrastim^® (XM02), a biosimilar recombinant human granulocyte colony-stimulating factor

Abstract:

Since the expiration of the patent for filgrastim in Europe in 2006, the European Medicines Agency has approved three biosimilar granulocyte colony-stimulating factors, while the US Food and Drug Administration has approved one of these agents. Using the European Medicines Agency’s and the Food and Drug Administration’s regulatory reports and scientific publications, we review the evidence about the clinical efficacy and safety of XM02 (Tevagrastim^®) relative to the originator product filgrastim (Neupogen^®). Clinical efficacy is assessed in terms of equivalence of XM02 and Neupogen^®, while safety is evaluated in terms of immunogenicity, bone pain, splenomegaly, allergic reactions, acute respiratory distress syndrome, and mortality. Three Phase III studies in breast cancer patients treated with docetaxel/doxorubicin chemotherapy, lung cancer patients receiving platinum-based chemotherapy, and non-Hodgkin’s lymphoma receiving chemotherapy are reviewed. Also included is a postapproval, single-center experience study on peripheral blood stem mobilization. Based on the available therapeutic equivalence and safety data, the clinical and safety outcomes of XM02 are likely to be similar to those of Neupogen^®. XM02 and Neupogen^® can be considered interchangeable in the approved indications. Patients previously on Neupogen^® and converted to XM02 can be expected to show similar efficacy and safety outcomes.

Keywords::

• biosimilars
• biosimilar pharmaceuticals
• efficacy
• safety
• granulocyte colony-stimulating factor
• recombinant proteins