title: Position paper of Italian rheumatologists on the use of biosimilar drugs.
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.
authors.affiliation: Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.
authors.forename: Fabiola
authors.initials: F
authors.lastname: Atzeni
authors.affiliation: Rheumatology Unit, University of Modena and Reggio Emilia, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Sebastiani
authors.affiliation: Institute of Epidemiology and Preventive Medicine, University of Regensburg, Germany.
authors.forename: Cristian
authors.initials: C
authors.lastname: Ricci
authors.affiliation: Association of Patients with Rheumatic Diseases Onlus, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Celano
authors.affiliation: Rheumatology Unit, Sacro Cuore Catholic University, Rome, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Gremese
authors.affiliation: Rheumatology Unit, University of Bari, Italy.
authors.forename: Florenzo
authors.initials: F
authors.lastname: Iannone
authors.affiliation: Rheumatology Unit, University of Milan, Italy.
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Meroni
authors.affiliation: Department of Pharmaceutical Sciences, University of Milan, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Minghetti
authors.affiliation: Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.
authors.forename: Piercarlo
authors.initials: P
authors.lastname: Sarzi-Puttini
authors.affiliation: Rheumatology Unit, Sacro Cuore Catholic University, Rome, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Ferraccioli
authors.affiliation: Rheumatology Unit, University of Bari, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lapadula
mesh_terms: D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use*; D057915:Drug Substitution; D004335:Drug and Narcotic Control; D006801:Humans; D007258:Informed Consent; D007558:Italy; D010330:Patents as Topic; D061214:Patient Safety; D012216:Rheumatic Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D012219:Rheumatology / Q000592:standards*; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals