The study pesented at the American Diabetes Association 77th Scientific Sessions compared Mylan/Biocon’s MYL-1501D, a proposed biosimilar to Sanofi-Aventis’ insulin glargine, with the reference product.
A double-blind, randomized, 3-way crossover study comparing the pharmacokinetics (PK) and pharmacodynamics (PD) of MYL-1501D, Mylan/Biocon’s proposed biosimilar to Sanofi-Aventis’ originator insulin glargine (US and EU versions of Lantus) reported PK/PD equivalence between the 3 products in 114 patients with type 1 diabetes (T1D). The findings, presented during a poster session at the American Diabetes Association 77th Scientific Sessions on June 10, 2017, in San Diego, also showed that both insulin glargine and the biosimilar were generally well tolerated and did not display significant safety issues.
Lead researcher Tim Heise, MD, of Profil Institut fur Stoffwechselforschung GmbH, Neuss, Germany, and colleagues noted that the study’s analysis of PK/PD factors were performed to meet the guidance issued by the FDA and the European Medicines Agency (EMA) on the development and approval of biosimilars to show biosimilars are comparable to the originator biologic product. Therefore, the objective of the study was to evaluate PK/PD bioequivalence with regard to total and maximum plasma insulin concentrations of the 3 insulin glargine preparations, each administered by subcutaneous injection of a single dose of 0.4 U/kg in patients with T1D.
Patients included in the study were generally healthy male or female nonsmokers aged 18 to 55 years who had a body mass index between 18.5 and 29.9 kg/m2 and were on stable insulin treatment for at least 6 months before the screening visit. Patients with insulin resistance were excluded from the study.
The study met its primary PK endpoints; mean serum insulin and plasma metabolite concentration profiles of the 3 insulin glargine preparations were shown to be similar. Additionally, the 3 drugs had nearly identical glucose infusion rate (GIR) profiles, which was the primary PD endpoint. Thus, the study demonstrated bioequivalence of MYL-1501D and the US and EU versions of Lantus in T1D patients for the primary PK and PD end points.
Rates of adverse events (AEs) observed were similar for the 3 insulin glargine formulations, with no serious AEs or AEs leading to withdrawal.
Currently, the only FDA-approved “follow-on” insulin product in the United States is Eli Lilly’s Basaglar, a biosimilar of Sanofi’s Lantus, which was approved in late 2015. The FDA is currently reviewing other insulin glargine analogs.
Mylan announced that the data presented from this study and others on MYL1501D in patients with type 1 and type 2 diabetes confirmed its efficacy, safety, and immunogenicity in comparison with Lantus.