PDB2 - Efficacy and Safety of Biosimilar Insulins Compared to Their Reference Products: A Systematic Review

Abstract

To summarize the scientific evidence comparing the safety, efficacy, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products. We conducted a systematic review using PubMed, Cochrane, Embase, Latin America and Caribbean Health Sciences (LILACS), South Asian Database of Controlled Clinical Trials (SADCCT), and IndiaMED from inception of biosimilar insulins through September 7, 2016. We 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. Two researchers independently reviewed all titles, abstracts and text; extracted data; and performed quality assessments. Outcomes and measures of interest were efficacy, safety, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products. Of 5,886 articles screened, six studies were included in the data synthesis. The trials investigated LY2963016, Basalog and Basalin, all with insulin glargine (Lantus) as a reference product. Two trials included healthy volunteers, three enrolled type 1 diabetics and one enrolled type 2 diabetics. Of the six studies, three examined pharmacokinetic and/or pharmacodynamic parameters and three 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. Few published studies have compared biosimilar and reference insulins, though those that have suggest that biosimilar glargine has comparable safety and clinical efficacy as its reference product.