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While these non-innovator products are not biosimilars, they illustrate the difficulties facing regulators to ensure the quality and safety of biosimilar products.

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All patients had sinus rhythm on the ECG obtained at hospital discharge and were followed up 7 years.

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Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multi-center, open-labeled, randomized trial.

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The trial was successful, and the results were published in the in January 1987.

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Between 1998 and 2000, 13 such cases were reported from France--12 in patients who had received the Eprex formulation of epoetin alfa and 1 in a patient who had received Neorecormon (a formulation of epoetin beta); both are products that are marketed outside the United States.

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In 1998, epoetin-associated pure red cell aplasia (PRCA) was first reported and causation was attributed to formulations without human serum albumin (HSA), subcutaneous administration, and uncoated rubber stoppers.

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