Modulo dichiarazione conflitto di interessi

Tutti i rapporti finanziari intercorsi negli ultimi due anni devono essere dichiarati.

Non ho rapporti (finanziari o di altro tipo) con le Aziende del farmaco

Ho / ho avuto rapporti (finanziari o di altro tipo) con le Aziende del farmaco

x

Relationship Company/Organization

Giorgio Minotti

Dipartimento di Medicina

Università Campus Bio-Medico

Roma

Alcuni concetti minimali sui biosimilari

Roma, 17 maggio 2019

brand lot 1 brand lot 2 brand lot 3

brand EU lot 1 brand EU lot 2 brand US lot #

lot 1 lot 2 lot 3

brand biosimilar

Hanes et al., Cancer Chemother Pharmacol 2017

The goal of the development process of biosimilars is to demonstrate similarity to the reference product (RP) rather than patient benefit per se, as this was established for the RP

Thill, Breast Care 2019

Therefore, no survival endpoints such as event-free survival (EFS), disease-free survival, progression-free survival (PFS), and OS, the preferred endpoints to prove efficacy in cancer, are recommended to be used

Thill, Breast Care 2019

Thill, Breast Care 2019

non superiority > importante di non inferiority importanza delle sensitivity analyses

Pivot et al, EJC 2018

Rugo et al, JAMA 2017

Rezk and Pieper, Rheumatol Ther 2017