Atzeni, F. and Sebastiani, M. and Ricci, C. and Celano, A. and Gremese, E. and Iannone, F. and Meroni, P. L. and Minghetti, P. and Sarzi-Puttini, P. and Ferraccioli, G. and Lapadula, G. (2015) Position paper of Italian rheumatologists on the use of biosimilar drugs. CLINICAL AND EXPERIMENTAL RHEUMATOLOGY, 33 (1). pp. 1-4. ISSN 0392-856X,
Full text not available from this repository. (Request a copy)Abstract
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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PLACEBO-CONTROLLED TRIAL; RHEUMATOID-ARTHRITIS; ANKYLOSING-SPONDYLITIS; INNOVATOR INFLIXIMAB; PARALLEL-GROUP; DOUBLE-BLIND; EFFICACY; SAFETY; METHOTREXATE; CT-P13; biosimilar drugs; immunogenicity; clinical trials |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Institut für Epidemiologie und Präventivmedizin |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 31 Jul 2019 10:05 |
| Last Modified: | 31 Jul 2019 10:05 |
| URI: | https://pred.uni-regensburg.de/id/eprint/6275 |
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