The Medical Letter n. 20 / 2021
Nr. 20 del 15/10/2021
TML n. 20 / 2021 INSULINA GLARGINE INTERCAMBIABILE
La Food and Drug Administration (FDA) ha concesso all’insulina glargine-yfgn (Semglee-Viatris negli USA; non disponibile in commercio in Italia), un prodotto follow-on dell’ insulina glargine, lo status di intercambiabilità con il prodotto di riferimento Lantus (Sanofi). È il primo farmaco a base di insulina bioequivalente a ricevere questa designazione negli Stati Uniti. Ora il farmacista può sostituire Lantus con Semglee come alternativa a basso costo senza l’autorizzazione del medico prescrittore.
Un bioequivalente è un prodotto biologico altamente simile e privo di differenze clinicamente significative rispetto al prodotto di riferimento. Affinché un bioequivalente sia approvato come prodotto intercambiabile, il produttore deve condurre studi clinici che dimostrino che, se il paziente passa dal prodotto di riferimento al bioequivalente, i risultati saranno gli stessi.
Questo è l'abstract dell'articolo. Per poter consultare l'intero numero o più numeri scegli il tipo di abbonamento che preferisci.
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