TY - JOUR
T1 - Position paper of Italian rheumatologists on the use of biosimilar drugs
AU - Gremese, Elisa
AU - Ferraccioli, Gianfranco
AU - Atzeni, Fabiola
AU - Sebastiani, Marco
AU - Ricci, Cristian
AU - Celano, Antonella
AU - Iannone, Florenzo
AU - Meroni, Pier Luigi
AU - Minghetti, Paola
AU - Sarzi-Puttini, Piercarlo
AU - Lapadula, Giovanni
PY - 2014
Y1 - 2014
N2 - The recent availability of biosimilars as a result of the expiry of the patents of first-generation biotechnological drugs may theoretically reduce the direct costs of such treatments, making their use accessible to a larger number of patients. However, the currently available clinical data refer to a relatively small number of patients, and do not provide sufficient information concerning long-term efficacy and safety or the frequency of rare adverse events. Given the importance of the introduction of biosimilar drugs and the limitations of our current knowledge of their efficacy and safety profiles, we believe it is mandatory to draw up a position paper for Italian Rheumatologists. Moreover, in order to guarantee their safety, it is mandatory to indicate behavioural rules for the involved specialists and competent authorities, and perform ad hoc clinical trials and appropriate drug surveillance.
AB - The recent availability of biosimilars as a result of the expiry of the patents of first-generation biotechnological drugs may theoretically reduce the direct costs of such treatments, making their use accessible to a larger number of patients. However, the currently available clinical data refer to a relatively small number of patients, and do not provide sufficient information concerning long-term efficacy and safety or the frequency of rare adverse events. Given the importance of the introduction of biosimilar drugs and the limitations of our current knowledge of their efficacy and safety profiles, we believe it is mandatory to draw up a position paper for Italian Rheumatologists. Moreover, in order to guarantee their safety, it is mandatory to indicate behavioural rules for the involved specialists and competent authorities, and perform ad hoc clinical trials and appropriate drug surveillance.
KW - Rheumatologist
KW - drugs
KW - Rheumatologist
KW - drugs
UR - http://hdl.handle.net/10807/64701
M3 - Article
SP - N/A-N/A
JO - CLINICAL AND EXPERIMENTAL RHEUMATOLOGY
JF - CLINICAL AND EXPERIMENTAL RHEUMATOLOGY
SN - 1593-098X
ER -