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Protein isolated from biopharmaceutical formulations cannot be used for comparative studies: follow-up to “a case study using epoetin Alfa from Epogen and EPREX” J Pharm Sci.

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In such a paradigm, biosimilar sponsors would have early, effective and active dialogue (known as a stepwise approach) with the FDA to understand what this “totality of the evidence” data package should include, especially in terms of understanding what kind of toxicological and clinical data will be required.

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Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.

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He showed that the overall response rate to CsA is excellent (65%) and proposed that CsA should be the first drug to be given in acquired PRCA.

Detailed studies regarding the use of CD spectra for structural comparisons in comparability studies have been published recently (Li et al.

Pretreatment normalization of mild anemia with epoetin alfa predicts long-term outcome for women with epithelial ovarian cancer.

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Autoantibodies to erythropoietin receptor in patients with immune-mediated diseases: relationship to anaemia with erythroid hypoplasia.

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The federal agency said the German study is investigating whether the anti-anemia drug epoetin alfa, marketed as Eprex in Germany, can improve the neurological functioning of stroke victims.

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Amgen, Synthon, and Watson (now Actavis): Global licensing agreement announced July 18, 2012, for clinical development and testing of biosimilar.

The agency said that the finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in these trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.

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Patients were selected for study when they ( 1) began dialysis between 1995 and 2000, ( 2) had Medicare as their primary payer, ( 3) were 65 yr old or older at initiation of dialysis therapy, ( 4) had no erythropoietin claims before initiation of dialysis therapy, and ( 5) did not have a switch in dialysis modality in the first 6 mo of dialysis therapy (study entry period).

In December 2002, regulatory authorities in Europe advised that subcutaneous administration of Eprex to patients on hemodialysis was contraindicated.

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The most recent practice guidelines in CKD anemia recommend intravenous iron in hemodialysis patients, but either oral or IV in either peritoneal dialysis or non-dialysis CKD patients receiving ESA therapy.

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Although the four products were similar in terms of their molecular profiles and anticoagulant potencies, as measured by activated partial thromboplastin time (aPTT), there were marked differences between the biosimilar formulations in thrombin time (TT) and in Heptest (American Diagnostica), a heparin clotting assay kit ().

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Mandreoli and coworkers reported an 80-year-old hemodialysis patient who developed antibody-associated PRCA after 4 months of subcutaneous Eprex administration.

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