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Recommandations d’utilisation des biosimilaires de l’érythropoïétine (EPO). Propositions de la Société de néphrologie, de la Société francophone de dialyse et de la Société de néphrologie pédiatrique

2008; Elsevier BV; Volume: 5; Issue: 1 Linguagem: Francês

10.1016/j.nephro.2008.10.006

1872-9177

Jean-Louis Bouchet, Philippe Brunet, Bernard Canaud, Jacques Chanliau, Christian Combe, Gilbert Deray, Pascal Houillier, O Kourilsky, Elena Ledneva, Patrick Niaudet, J. Agustín Pachón Ortíz, Mira Pavlovic, Jean‐Philippe Ryckelynck, E Singlas, David Verhelst,

Clinical Laboratory Practices and Quality Control

The European patents for epoetin alpha recently expired. Biosimilars (i.e. "a medicine which is similar to a biological medicine that has already been authorized" [EMEA 2007]) of epoetins have thus been released on the market in Europe. Because of the complexity of the processes that are required to produce medicinal products containing biotechnology-derived proteins as active substances and to characterize the physicochemical properties of these compounds, the guidelines that have been developed for generic drugs cannot be used for approval of biosimilar products. The EMEA guidelines do not answer all questions that have been raised for the development of biosimilars, and in some cases, decisions will have to be taken at a national level. This is why the Society of Nephrology (Société de néphrologie), the French-speaking Society of Dialysis (Société francophone de dialyse) and the Pediatric Society of Nephrology (Société de néphrologie pédiatrique) established guidelines for the usage of biosimilar epoetins concerning approval, identification, substitution of an innovator drug, post-marketing surveillance, extension of indication and pharmacovigilance plan.