Lettre ouverte à Madame La Minis tre de la Santé-AB

!
!
! Ministère!des!affaires!sociales,!de!!
!la!santé!des!droits!des!femmes!
! Madame!Marisol!TOURAINE!
!14!avenue!Duquesne!
! 75007!PARIS!
!
!
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./%/(#!"/!.01023*#4!
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L’arrivée!des!biosimilaires!dans!les!options!thérapeutiques!de!nos!pathologies! permettra!
de!réaliser!des!économies!de!santé!dont!nous!sommes!conscients.!Cependant,!leur!mise!en!
place!suscite!des!préoccupations!que!nous!souhaitons!porter!à!votre!connaissance.!!
!
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Le!principe!d’extrapolation!
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Aussi,!nous!demandons!à!ce!que!des!résultats!d’études!observationnelles!soient!produits!
avant! la!confirmation! de! l’utilisation! d’un! biosimilaire! dans! une! indication,! ce! qui!
permettra!de!s’assurer!la!confiance!nécessaire!au!succès!des!biosimilaires!durablement.!
!
!
!
L’immunogénicité!
!
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anticorps*au*traitement*à*l’introduction*d’un*biosimilaire*après*traitement*de*référence.*
«!En#effet,#pour#un#même#patient,#les#changements#multiples#ou#fréquents#de#traitement#
entre%médicaments%déclarés%similaires%(incluant%le%médicament*de*référence),*pourraient*
exposer'à'un'risque'plus'élevé'de'réponse'immunologique'contre'la'protéine'd’intérêt'
thérapeutique+et+rendre+difficile+le+suivi+des+effets+indésirables,+en+particulier+d’origine+
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Aussi!nous!demandons!à!ce!que,!dans!un!premier!temps!et!selon!le!principe!de!précaution,!
seuls!les!patients!naïfs!de!biomédicaments!soient!traités!par!biosimilaire.!
!
Traçabilité,!pharmacovigilance!et!substitution!
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Aussi,!nous!demandons!à!ce!que!le!biosimilaire!reste!un!traitement!de!prescription!et!non!
pas!de!substitution.!
!
Information!
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Aussi,!nous!demandons!à!ce!que!l’information!au!malade!soit!systématique.!
!
Pourquoi!une!accélération!des!procédures!?!
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Aussi,!nous!demandons!à!ce!que!le!décret!d’application!tienne!compte!de!nos!remarques!
en!imposant!à!minima!:!
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