L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a modifi\u00e9, par une d\u00e9cision de sa directrice g\u00e9n\u00e9rale en date du 31 ao\u00fbt 2026, la liste de r\u00e9f\u00e9rence des groupes biologiques similaires mentionn\u00e9e \u00e0 l\u2019article R. 5121-9-1 du code de la sant\u00e9 publique. Cette d\u00e9cision s\u2019inscrit dans le cadre de la d\u00e9cision initiale du 13 octobre 2017 portant inscription de ces groupes sur la liste de r\u00e9f\u00e9rence.<\/p>\n
L\u2019annexe I de la d\u00e9cision de 2017 est compl\u00e9t\u00e9e par l\u2019ajout de nouveaux m\u00e9dicaments biologiques similaires pour plusieurs substances actives. Pour l\u2019\u00e9tanercept, le m\u00e9dicament de r\u00e9f\u00e9rence Enbrel se voit associer le biosimilaire Fubelv. Pour le tocilizumab, le m\u00e9dicament de r\u00e9f\u00e9rence Roactemra est d\u00e9sormais associ\u00e9 au biosimilaire Tuyory. Pour l\u2019insuline asparte, le m\u00e9dicament de r\u00e9f\u00e9rence Novorapid est compl\u00e9t\u00e9 par le biosimilaire Dazparda.<\/p>\n
La d\u00e9cision cr\u00e9e \u00e9galement un nouveau groupe biologique similaire pour la substance active pertuzumab, avec le m\u00e9dicament de r\u00e9f\u00e9rence Perjeta et le m\u00e9dicament biologique similaire Poherdy.<\/p>\n
La d\u00e9cision pr\u00e9cise que ces modifications seront publi\u00e9es sur le site internet de l\u2019ANSM. Elle est sign\u00e9e par la directrice g\u00e9n\u00e9rale de l\u2019Agence, Catherine Paugam Burtz, et publi\u00e9e le 1er septembre 2026. Elle concerne directement la r\u00e9gulation des m\u00e9dicaments biologiques similaires en France, sous l\u2019autorit\u00e9 du minist\u00e8re charg\u00e9 de la sant\u00e9 via l\u2019ANSM, sans pr\u00e9ciser d\u2019autres implications r\u00e9glementaires ou op\u00e9rationnelles.\u00a0(contenu r\u00e9sum\u00e9 par l’IA)Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":" L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a modifi\u00e9, par une d\u00e9cision de sa directrice g\u00e9n\u00e9rale en date du 31 ao\u00fbt 2026, la liste de 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