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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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It was generally agreed that there were insufficient new data to justify an immediate revision of the anaemia guidelines.

Entry of biosimilars onto the market will require transparent, unbiased dissemination of information to prescribers and other healthcare professionals.

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Its currently approved therapeutic indications by both organisations include the empirical therapy of presumed fungal infections in febrile, neutropenic adult patients and the treatment of invasive aspergillosis in adult patients whose disease is refractory to, or who are intolerant of, other antifungal agents (i.

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CRF patients who had been receiving stable doses of other recombinant erythropoietins were randomized to Aranesp ä, or to continue with their prior erythropoietin at the previous dose and schedule.

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Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Rydén L, Neal B, Malmberg 7, Wedel H, Buse JB, Henry RR, Weichert A, Cannata R, Svensson A, Volz D, Grobbee DE, AleCardio Investigators (Tiong Kiam Ong).

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This prospective study included 25 patients, 13 (52%) males and 12(48%) females treated in our institute from February till September, 2007.

National Institute for Health and Clinical Excellence in 2010.

In fact, no specific efficacy or safety issues have been identified in clinical practice for biosimilar epoetins licensed in Europe.

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Second, what scientific and technical factors should the agency consider in determining the appropriate analytical, animal, and clinical study or studies to assess the nature and impact of actual or potential structural differences between the proposed biosimilar product and the reference product?

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Suppression of erythropoietin production or suppression of the bone marrow response to erythropoietin has resulted in anemias in several disease processes to include renal disease, cancer treatment, other chronic diseases and use of certain drugs.

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Correction of anemia with epoetin alfa in chronic kidney disease.

Predictors of mortality in patients with Acute Coronary Syndrome (ACS) undergoing Percutaneous Coronary Intervention (PCI): Insights from National Cardiovascular Disease Database (NCVD), Malaysia.

In the present analysis, biosimilar epoetin α remains cost efficient relative to darbepoetin α for both fixed and weight-based dosing even if only continuous standard dosing is considered.

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Methods and results: The study enrolled 203 persons divided in two groups.

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