Importance\nFor nearly a century, no generic form of insulin has been available in the United States.\nHowever, the first biosimilar insulin, Basaglar, was approved by the U.S. Food and Drug\nAdministration in 2015, and subsequently Admelog and Lusduna in 2017.\nObjective\nTo summarize the scientific evidence comparing the safety, efficacy, pharmacokinetics, and\npharmacodynamics of biosimilar and reference insulin products.\nData sources\nWe conducted a systematic review using PubMed, Cochrane, Embase, Latin America and\nCaribbean Health Sciences, South Asian Database of Controlled Clinical Trials, and\nIndiaMED from their inception through January 14, 2018.\nStudy selection\nWe included randomized controlled trials (RCTs) comparing safety, clinical efficacy, pharmacokinetics\nand pharmacodynamics of any biosimilar insulin with a reference product in\nadults regardless of sample size and location.\nData extraction and synthesis\nTwo researchers independently reviewed all titles, abstracts and text; extracted data; and\nperformed quality assessments.\nMain outcomes and measures\nEfficacy, safety, pharmacokinetics, and pharmacodynamics of biosimilar and reference\ninsulin products\nResults\nOf 6945 articles screened, 11 studies were included in the data synthesis. LY2963016,\nBasalog, Basalin, and MK-1293 were compared to Lantus while SAR342434 was compared\nto Humalog. Three trials enrolled healthy volunteers, five enrolled type 1 diabetics, and two\nenrolled type 2 diabetics. One study enrolled both healthy and type 1 diabetics. Of the\neleven studies, six examined pharmacokinetic and/or pharmacodynamic parameters and\nfive examined clinical efficacy and immunogenicity. All studies included adverse events. All\nPK and/or PD studies showed that comparable parameters of biosimilar and reference products\nwere within the pre-specified equivalence margins. Clinical studies suggested similar\nclinical efficacy and immunogenicity. Adverse events were similar between the groups\nacross all studies.\nConclusions and relevance\nFew published studies have compared biosimilar and reference insulins, though those that\ndid suggest that the biosimilars have comparable safety and clinical efficacy as its reference\nproduct.
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