[Position statements regarding usage of biosimilars of Epoetins. Position paper of the Société de néphrologie, Société francophone de dialyse, and Société de néphrologie pédiatrique].
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.
Bouchet
Jean-Louis
JL
CTMR Saint-Augustin, 106, avenue d'Ares 33000 Bordeaux, France.
Brunet
Philippe
P
Canaud
Bernard
B
Chanliau
Jacques
J
Combe
Christian
C
Deray
Gilbert
G
Houillier
Pascal
P
Kourilsky
Olivier
O
Ledneva
Elena
E
Niaudet
Patrick
P
Ortiz
Jean-Paul
JP
Pavlovic
Mira
M
Ryckelynck
Jean-Philippe
JP
Singlas
Eric
E
Verhelst
David
D
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
D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa