Abstract
ImportanceFor nearly a century, no generic form of insulin has been available in the United States. However, the first biosimilar insulin, Basaglar, was approved by the U.S. Food and Drug Administration in 2015, and subsequently Admelog and Lusduna in 2017.ObjectiveTo summarize the scientific evidence comparing the safety, efficacy, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products.Data sourcesWe conducted a systematic review using PubMed, Cochrane, Embase, Latin America and Caribbean Health Sciences, South Asian Database of Controlled Clinical Trials, and IndiaMED from their inception through January 14, 2018.Study selectionWe included randomized controlled trials (RCTs) comparing safety, clinical efficacy, pharmacokinetics and pharmacodynamics of any biosimilar insulin with a reference product in adults regardless of sample size and location.Data extraction and synthesisTwo researchers independently reviewed all titles, abstracts and text; extracted data; and performed quality assessments.Main outcomes and measuresEfficacy, safety, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin productsResultsOf 6945 articles screened, 11 studies were included in the data synthesis. LY2963016, Basalog, Basalin, and MK-1293 were compared to Lantus while SAR342434 was compared to Humalog. Three trials enrolled healthy volunteers, five enrolled type 1 diabetics, and two enrolled type 2 diabetics. One study enrolled both healthy and type 1 diabetics. Of the eleven studies, six examined pharmacokinetic and/or pharmacodynamic parameters and five examined clinical efficacy and immunogenicity. All studies included adverse events. All PK and/or PD studies showed that comparable parameters of biosimilar and reference products were within the pre-specified equivalence margins. Clinical studies suggested similar clinical efficacy and immunogenicity. Adverse events were similar between the groups across all studies.Conclusions and relevanceFew published studies have compared biosimilar and reference insulins, though those that did suggest that the biosimilars have comparable safety and clinical efficacy as its reference product.
Highlights
Biopharmaceuticals, or products derived from living cells, represent a growing and important sector of the pharmaceutical marketplace [1]
All PK and/or PD studies showed that comparable parameters of biosimilar and reference products were within the pre-specified equivalence margins
Few published studies have compared biosimilar and reference insulins, though those that did suggest that the biosimilars have comparable safety and clinical efficacy as its reference product
Summary
Biopharmaceuticals, or products derived from living cells, represent a growing and important sector of the pharmaceutical marketplace [1]. They account for only a small proportion of all pharmaceutical treatments, yet are estimated to generate global revenues of $221 billion, making up about 20% of the pharmaceutical market, in 2017 [2]. While there are dozens of biopharmaceuticals currently available in the United States, one of the first to market was recombinant human insulin. The first biosimilar insulin in United States, Basaglar, was approved for marketing in 2015, followed by Admelog and Lusduna in 2017 [5,6,7]. Biosimilar insulins have been available in India (Glaritus, Glarvia, Basalog, Wosulin, Insugen, Biosulin), China (Basalin, Comonlin, Prandilin), Mexico (Bonglixan), Europe (Abasaglar) and other parts of Asia for more than a decade [8,9,10,11]
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