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The manufacturer is doing a postauthorisation, 3-year observational study investigating biosimilar epoetin zeta given by subcutaneous injection to 6700 European patients with anaemia associated with renal disease (trial registration number PMS-830-09-0082).

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The desired pharmacologic effect of epoetin is mediated by a single cell receptor, and the mechanism of action is the same in all approved indications.

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FDA approval allows marketing of XM02 for the indication assessed in pivotal trials (prevention of febrile neutropenia after chemotherapy) and it does not require postapproval pharmacovigilance studies.

Because there were no substantive differences in the rates of adverse reactions between these subpopulations, or between these subpopulations and the entire population of patients treated with Aranesp ä, data from all 1598 patients were pooled.

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This article specifically addresses the concerns raised about the use of biosimilars in extrapolated indications and explains the underlying science and regulatory decision making, including some real-life examples from recently licensed biosimilars.

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Europe was discontinued after two patients with renal anaemia developed antibody-mediated PRCA after being given the subcutaneous epoetin biosimilar HX575.

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