Position statements regarding usage of biosimilars of Epoetins. Position paper of the Société de néphrologie, Société francophone de dialyse, and Société de néphrologie pédiatrique;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

Nephrologie et Therapeutique

Volumn 5, Issue 1, 2009, Pages 61-66

  Bouchet, Jean Louis ^a   Brunet, Philippe ^b   Canaud, Bernard ^c   Chanliau, Jacques ^d   Combe, Christian ^e   Deray, Gilbert ^f   Houillier, Pascal ^g   Kourilsky, Olivier ^h   Ledneva, Elena ^f   Niaudet, Patrick ⁱ   Ortiz, Jean Paul ^j   Pavlovic, Mira ^k   Ryckelynck, Jean Philippe ^l   Singlas, Eric ⁱ   Verhelst, David ^m  

^a CTMR Saint Augustin   (France)

^b AIX MARSEILLE UNIVERSITY   (France)

^c LAPEYRONIE HOSPITAL   (France)

^d ALTIR   (France)

^e HÔPITAL PELLEGRIN   (France)

^f PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^g HÔPITAL EUROPÉEN GEORGES POMPIDOU   (France)

^h CENTRE HOSPITALIER SUD FRANCILIEN   (France)

ⁱ HÔPITAL NECKER ENFANTS MALADES   (France)

^j Centre d'hémodialyse Saint Roch   (France)

^k AFSSAPS   (France)

^l CHU Clemenceau   (France)

^m CENTRE HOSPITALIER D AVIGNON   (France)

more..

Author keywords

Biosimilars; Epoetin; Position statement

Indexed keywords

GENERIC DRUG; RECOMBINANT ERYTHROPOIETIN;

BIOTECHNOLOGY; DRUG APPROVAL; DRUG IDENTIFICATION; DRUG SURVEILLANCE PROGRAM; MEDICAL SOCIETY; PHYSICAL CHEMISTRY; PRACTICE GUIDELINE; SHORT SURVEY;

EID: 59349102800     PISSN: 17697255     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.nephro.2008.10.006     Document Type: Article

References (5)

1. Société de néphrologie, Société francophone de dialyse, Société de néphrologie pédiatrique. Position statement regardind usage of biosimilars: position paper of the Société de néphrologie, Société francophone de dialyse and de Société de néphrologie pédiatrique. Nephrol Ther 2 (2006) 432-435 [Article in English and French]
2. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. CHMP/BWP/49 348/2005.
3. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non clinical and clinical issues. CHMP/BMWP/42 832/2005.
4. Annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non clinical and clinical issues; guidance on biosimilar medicinal products containing recombinant erythropoietin. CHMP/94 526/2005.
5. Keithy-Reddy S.R., Kandasamy S., and Singh A.K. Pure red cell aplasie due to follow-on epoetin. Kidney Int (2008)