title: Biosimilars: a systematic review of published and ongoing clinical trials of antipsoriatics in chronic inflammatory diseases.
abstract: Biosimilars for psoriasis treatment are currently being developed. Comparison of their efficacy and safety is a challenge. For approval, the European Medicines Agency (EMA) considers indirect evidence from other indications (for example, rheumatoid arthritis) as sufficient. Systematic review of biosimilars for psoriasis and other indications, review of ongoing trials in trial registers. Systematic search for randomized controlled trials (RCT) on biosimilars to adalimumab, etanercept, infliximab, and ustekinumab compared to their reference medication: (1) Publications in Medline, Medline In-Process, Embase, Cochrane Library (efficacy, safety, immunogenicity) and (2) ongoing studies in clinical trial registers. No trials on biosimilars in psoriasis patients were identified. As to the infliximab biosimilar, there is data on patients with ankylosing spondylitis and rheumatoid arthritis, indicating no clinically relevant differences regarding efficacy and safety. Currently, there are two registered studies of an adalimumab biosimilar and one study of an etanercept biosimilar in psoriasis patients. Further ongoing studies on biosimilars to adalimumab, etanercept, and infliximab - all in rheumatoid arthritis patients - were identified. There is currently only limited data regarding RCTs with biosimilars. Provision of further clinical data and inclusion of patients in patient registers will be crucial.
authors.affiliation: Division of Evidence Based Medicine (dEBM), Department of Dermatology, Charitè - Universitätsmedizin Berlin, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Nast
authors.forename: Stefanie
authors.initials: S
authors.lastname: Rosumeck
authors.forename: Karin
authors.initials: K
authors.lastname: Seidenschnur
mesh_terms: D001688:Biological Products / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D002908:Chronic Disease; D003879:Dermatologic Agents / Q000627:therapeutic use*; D006801:Humans; D007249:Inflammation / Q000188:drug therapy* / Q000453:epidemiology; D011565:Psoriasis / Q000188:drug therapy* / Q000453:epidemiology; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D016896:Treatment Outcome
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D003879:Dermatologic Agents