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By inhibiting the formation of TNF-α, iron therapy may reduce disease activity in rheumatoid arthritis or end-stage renal disease.
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Erythropoietin reduces anemia and transfusions after chemotherapy with paclitaxel and carboplatin.
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Two original products, Eprex (epoetin alfa) and Dynepo (epoetin delta), and two biosimilar products, Binocrit (epoetin alfa) and Retacrit (epoetin zeta), were compared using (1) high performance size exclusion chromatography, (2) ELISA, (3) SDS-PAGE, (4) capillary zone electrophoresis and (5) in-vivo potency.
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In subsequent Omnitrope formulations no patient developed antibodies against GH and 1 patient developed anti-HCP antibodies during the 12 months study (data on file with Sandoz).
Cardiac output was measured (thermo-dilution) and mean cardiac index was calculated from three measurements (all patients in sinus rhythm) at baseline and after every 50W during the test.
Neutralizing effects of antibodies are confirmed in bioassays involving growth of primary marrow culture or an erythroleukemic cell line.
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This Committee oversees and coordinates the activities of the Company's three business segments: Consumer, Pharmaceutical and Medical Devices.
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Although some of these were studies of ESAs used during radiotherapy or for anemia of cancerboth off-label usesthe data nonetheless raises concerns about the use of ESAs for all cancer indications to include labeled indications.
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PRCA (anemia associated with neutralizing antibodies includes both PRCA and severe anemia, with or without a decrease in white blood cells or platelets associated with neutralizing antibodies), rare instances of PRCA with long-termuse of Epogen, Procrit, or darbepoetin had been identified.
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INN) for these products is epoetin zeta rather than epoetin alfa.
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The relationship of erythropoietin and iron metabolism to red blood cell production in humans.
The evidence reviewed and the comments received support the continuing determination that ESAs are not reasonable and necessary in beneficiaries with erythropoietin-type resistance due to neutralizing antibodies.
In 2002, Roche reported that PRCA due to epoetins was unlikely to be a class effect.
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Novel erythropoiesis stimulating protein (NESP), also called darbepoetin alfa (Aranesp), lasts longer in the blood than epoetin alfa and requires fewer injections.
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Consideration should also be given to whether there are any potentially unwanted immune effects that pose particular risk to the intended clinical population.
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Immunogenicity testing of the biosimilar and the reference product should be conducted within the biosimilar comparability exercise by using the same assay format and sampling schedule.
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The PRCA responded to discontinuation of epoetin and continuation of immunosuppressive therapy.
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Several commenters discussed the use of ESA therapy in the setting of anemia related to kidney disease or other uses that are beyond the scope of the proposed decision.
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For this purpose, there must be a high level of physico-chemical characterization of the biosimilar product in comparison with all the information collected with the originator during the development process or through post-marketing experience.
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