Abstract
BackgroundMYL-1501D is a proposed biosimilar to insulin glargine. The noninferiority of MYL-1501D was demonstrated in patients with type 1 diabetes and type 2 diabetes in 2 phase 3 trials. Immunogenicity of MYL-1501D and reference insulin glargine was examined in both studies.MethodsINSTRIDE 1 and INSTRIDE 2 were multicenter, open-label, randomized, parallel-group studies. In INSTRIDE 1, patients with type 1 diabetes received MYL-1501D or insulin glargine over a 52-week period. In INSTRIDE 2, patients with type 2 diabetes treated with oral antidiabetic drugs, insulin naive or not, received MYL-1501D or reference insulin glargine over a 24-week period. Incidence rates and change from baseline in relative levels of antidrug antibodies (ADA) and anti–host cell protein (anti-HCP) antibodies in both treatment groups were determined by a radioimmunoprecipitation assay and a bridging immunoassay, respectively. Results were analyzed using a mixed-effects model (INSTRIDE 1) or a nonparametric Wilcoxon rank sum test (INSTRIDE 2).ResultsTotal enrollment was 558 patients in INSTRIDE 1 and 560 patients in INSTRIDE 2. The incidence of total and cross-reactive ADA was comparable between treatment groups in INSTRIDE 1 and INSTRIDE 2 (P > 0.05 for both). A similar proportion of patients had anti-HCP antibodies in both treatment groups in INSTRIDE 1 at week 52 (MYL-1501D, 93.9 %; reference insulin glargine, 89.6 %; P = 0.213) and in INSTRIDE 2 at week 24 (MYL-1501D, 87.3 %; reference insulin glargine, 86.9 %; P > 0.999).ConclusionsIn INSTRIDE 1 and INSTRIDE 2, similar immunogenicity profiles were observed for MYL-1501D and reference insulin glargine in patients with type 1 diabetes and type 2 diabetes, respectively.Trial registrationClinicalTrials.gov, INSTRIDE 1 (NCT02227862; date of registration, August 28, 2014); INSTRIDE 2 (NCT02227875; date of registration, August 28, 2014).
Highlights
MYL-1501D is a proposed biosimilar to insulin glargine
Diabetes mellitus is characterized by chronic hyperglycemia and can be classified into several distinct categories based on the underlying mechanism of the disease [1]
Reference insulin glargine was administered via subcutaneous injection at a dose adapted to patients’ blood glucose levels; dosing of MYL-1501D was guided by self-monitored blood glucose assessments, as suggested by the reference insulin glargine dosing algorithm
Summary
MYL-1501D is a proposed biosimilar to insulin glargine. The noninferiority of MYL-1501D was demonstrated in patients with type 1 diabetes and type 2 diabetes in 2 phase 3 trials. Type 2 diabetes is characterized by insulin deficiency and resistance to the physiological effects of insulin, resulting in hyperglycemia [1, 3]. Prandial insulin is administered around mealtime and is a component of therapy for most patients with type 1 diabetes. Basal insulin is administered daily as a common part of the treatment regimens for patients with type 1 or type 2 diabetes. Insulin glargine is a long-acting human insulin analogue that allows for once-daily basal use in patients with type 1 or type 2 diabetes [6]. MYL-1501D (developed jointly by Viatris Inc, Canonsburg, PA, and Biocon Limited, Bangalore, India), a proposed biosimilar/follow-on biologic to insulin glargine, has an amino acid sequence identical to reference insulin glargine (Lantus®; SanofiAventis US LLC, Bridgewater, NJ) [7]. In March 2020, insulins were transitioned to a new regulatory pathway in the United States: insulins are regulated as biologics and can serve as reference products for biosimilar or interchangeable products [8]
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