title: [Position statements regarding usage of biosimilars of Epoetins. Position paper of the Société de néphrologie, Société francophone de dialyse, and Société de néphrologie pédiatrique].
abstract: 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.
authors.affiliation: CTMR Saint-Augustin, 106, avenue d'Ares 33000 Bordeaux, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Bouchet
authors.forename: Philippe
authors.initials: P
authors.lastname: Brunet
authors.forename: Bernard
authors.initials: B
authors.lastname: Canaud
authors.forename: Jacques
authors.initials: J
authors.lastname: Chanliau
authors.forename: Christian
authors.initials: C
authors.lastname: Combe
authors.forename: Gilbert
authors.initials: G
authors.lastname: Deray
authors.forename: Pascal
authors.initials: P
authors.lastname: Houillier
authors.forename: Olivier
authors.initials: O
authors.lastname: Kourilsky
authors.forename: Elena
authors.initials: E
authors.lastname: Ledneva
authors.forename: Patrick
authors.initials: P
authors.lastname: Niaudet
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Ortiz
authors.forename: Mira
authors.initials: M
authors.lastname: Pavlovic
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Ryckelynck
authors.forename: Eric
authors.initials: E
authors.lastname: Singlas
authors.forename: David
authors.initials: D
authors.lastname: Verhelst
mesh_terms: D017277:Drug Approval; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005060:Europe; D006801:Humans; D011358:Product Surveillance, Postmarketing; D011994:Recombinant Proteins
chemical_list: D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa