Efficacy of recombinant erythropoietins: is there unity of international units?
نویسنده
چکیده
The European Medicines Evaluation Agency (EMEA) has developed guidelines to ensure similarity, ‘in terms of quality, safety and efficacy’, between similar biological medicinal products (biosimilars) in comparison to the originators (http://www.emea.eu.int). The quality and safety of biosimilar recombinant human erythropoietins (rhEPOs) has been previously discussed [1–3]. The present comment focuses on the comparability of the in vivo potency of rhEPOs, which is relevant to the economic use of erythropoiesis stimulating agents (ESAs), because biosimilar rhEPOs have been priced by up to 30% lower than the originators in some countries of the European Union (EU).
منابع مشابه
Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins (Revision)
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ورودعنوان ژورنال:
- Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
دوره 24 5 شماره
صفحات -
تاریخ انتشار 2009