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Position Paper

 

Position paper of Italian rheumatologists on the use of biosimilar drugs

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

 

  1. Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.
  2. Rheumatology Unit, University of Modena and Reggio Emilia, Italy.
  3. Institute of Epidemiology and Preventive Medicine, University of Regensburg, Germany.
  4. Association of Patients with Rheumatic Diseases Onlus, Italy.
  5. Rheumatology Unit, Sacro Cuore Catholic University, Rome, Italy.
  6. Rheumatology Unit, University of Bari, Italy.
  7. Rheumatology Unit, University of Milan, Italy.
  8. Department of Pharmaceutical Sciences, University of Milan, Italy.
  9. Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.
  10. Rheumatology Unit, Sacro Cuore Catholic University, Rome, Italy.
  11. Rheumatology Unit, University of Bari, Italy.

CER7634
2015 Vol.33, N°1
PI 0001, PF 0004
Position Paper

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PMID: 25436597 [PubMed]

Received: 31/05/2014
Accepted : 08/07/2014
In Press: 07/11/2014
Published: 03/03/2015

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.

Rheumatology Article