15 Jun Biosimilar Insulin Found Equivalent to Brand Lantus
MedicalResearch.com Interview with:
Professor Philip Home D.M., D.Phil
Professor of Diabetes Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Prof. Home: MK1293 is a biosimilar insulin designed with the same amino acid sequence, manufacturing process and formulation as originator insulin glargine (Lantus). This is the clinical proving study in type 1 diabetes, being a 24-week randomized study in 508 participants between MK1293 and Lantus. The primary efficacy endpoint of non-inferiority of HbA1c was met, as was a secondary of equivalence (difference in change from baseline 0.04 (95% CI -0.11, 0.19) %-units), with other measures including hypoglycaemia, insulin antibodies and adverse events also consistent with similarity.
MedicalResearch.com: What should readers take away from your report?
Prof. Home: This is one of a series of studies to confirm biosimilarity. Together with the pharmacokinetic and pharmacodynamic studies, and a parallel study in people with type 2 diabetes, biosimilarity with Lantus seems established, subject now of course to regulatory review. Accordingly clinicians will be able to use MK1293 once licensed in the same way and circumstances as they do Lantus.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Prof. Home: This is the main phase of the study, but we will collect further randomized data over a total of 52 weeks. This will enhance the robustness of the antibody and adverse event data. But for future biosimilar studies it would be good to have more robust glucose profile data, using perhaps continuous glucose monitoring, and this should also enhance measurement of experience of hypoglycaemia. The collection of clinic-sampled laboratory-measured fasting plasma glucose in people with type 1 diabetes again provided weak and clinically meaningless data, and should be dropped from future studies once the regulators accept this. We also measured neutralizing antibodies in an in vitro assay, but it did not seem to correlate with meaningful changes in glucose control or insulin dose.
MedicalResearch.com: Is there anything else you would like to add?
Prof. Home: No single study of new biosimilar insulins established clinical similarity, and made clear by the series of studies performed by Merck (MSD) on MK1293 or by Lilly on their product Basaglar/Abasaglar. It is the total package that matters. Even then these studies do not establish interchangeability (substitution of one insulin glargine for another without further patient education and enhanced monitoring), which might require a large switch study. It is important to realize that insulin action is very dose dependent in any individual person, meaning that switch with minimal monitoring would require confidence that preparations were within plus/minus 5% glucose-lowering activity.
Please note the following: Philip Home or institutions with which he is associated received funding from Merck (MSD) in association with the development of new insulins, and also from the other major insulin manufacturers, for his advisory, lecturing or research activities.
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Citation: Abstract presented at the 2016 American Diabetes Association Meeting
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