title: The use of biosimilars in immune-mediated disease: A joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper.
abstract: Biological agents are widely used in rheumatology, dermatology and inflammatory bowel disease. Evidence about their efficacy and safety has been strengthened for all those therapeutic indications over the last decade. Biosimilar agents are monoclonal antibodies similar to previously approved biologics. In the European Union, they have been approved for all the indications in the management of immune-mediated inflammatory diseases (IMIDs), although data only in rheumatoid arthritis and ankylosing spondylitis are currently available. Direct evidence on efficacy, safety, and immunogenicity of biosimilars is mandatory in psoriasis, psoriatic arthritis, and inflammatory bowel disease, as well as in children. Based on the current evidence in the literature, we present the joint official position of the Italian Societies of Rheumatology, Dermatology and Inflammatory Bowel Disease on the use of biosimilars in IMIDs.
authors.affiliation: IBD Center, IRCCS Humanitas, Rozzano, Milan, Italy. Electronic address: gionataf@gmail.com.
authors.forename: Gionata
authors.initials: G
authors.lastname: Fiorino
authors.affiliation: Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy.
authors.forename: Giampiero
authors.initials: G
authors.lastname: Girolomoni
authors.affiliation: Interdisciplinary Department of Medicine, University of Bari, Bari, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lapadula
authors.affiliation: Internal Medicine, "Cervello" Hospital, Palermo, Italy.
authors.forename: Ambrogio
authors.initials: A
authors.lastname: Orlando
authors.affiliation: IBD Center, IRCCS Humanitas, Rozzano, Milan, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Danese
authors.affiliation: Rheumatology Deparment of Lucania, San Carlo Hospital of Potenza and Madonna delle Grazie Hospital of Matera, Italy. Electronic address: i.olivieri@ospedalesancarlo.it.
authors.forename: Ignazio
authors.initials: I
authors.lastname: Olivieri
mesh_terms: D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000276:immunology; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy* / Q000276:immunology; D007558:Italy; D012871:Skin Diseases / Q000188:drug therapy* / Q000276:immunology; D012955:Societies, Medical
chemical_list: D059451:Biosimilar Pharmaceuticals