Dr. Elena Christofides
Credit: Endocrinology Associates
Results from a phase 3, multicenter, open-label equivalence study showed similar immunity between the originator insulin glargine (Lantus) and its proposed biosimilar (Basalin) in adult patients with type 2 diabetes. Efficacy, efficacy, and safety have been suggested.1
Patients treated with the biosimilar had similar positive rates of treatment-induced glycated hemoglobin by week 26 compared to patients treated with the originator, regardless of prior insulin glargine exposure. The frequency and nature of adverse events that occurred during treatment were also similar.1
“The advent of biosimilar insulins offers a promising path to reduce treatment costs compared to original insulin products while ensuring comparable efficacy and safety profiles,” Endocrinology Research Associates CEO Elena Christofides, MD, and colleagues write.1 “The introduction of these biosimilars aims to reduce the economic burden on both patients and healthcare systems while maintaining therapeutic efficacy and safety.”
According to the Centers for Disease Control and Prevention, approximately 38 million people in the United States have diabetes, and approximately 90 to 95 percent of them have type 2 diabetes.2 Insulin therapy is often an essential component of diabetes treatment to control blood sugar levels and prevent diabetes complications, but access is often hampered by the high cost of treatment. Biosimilars offer a potential solution to these cost barriers with comparable therapeutic efficacy and safety to reference products.1
To evaluate the immunogenicity, safety, and efficacy of the reference glargine compared to that of the proposed biosimilar, researchers studied 567 patients with type 2 diabetes seen at 57 institutions. We conducted a phase 3, multicenter, open-label, equivalence study on subjects and randomly assigned them. Either the standard Lantus or the biosimilar Basalin will be administered in a 1:1 ratio for 26 weeks. The primary endpoint was the proportion of participants who developed treatment-induced anti-insulin antibodies, while secondary endpoints included efficacy and safety measures, changes in glycated hemoglobin levels, and a comparative assessment of adverse events. It was.1
Participants who were already using insulin at the time of enrollment were required to continue their oral antidiabetic medication and replace basal insulin with the study drug. Participants who were not using basal insulin at enrollment continued their oral antidiabetic medication, added study medication, and had their insulin doses adjusted individually according to their metabolic status. The researchers noted that all participants underwent optimization and adjustment of insulin doses and oral antidiabetic drug doses as needed.1
Researchers randomly assigned 283 participants to the reference product and 284 to the biosimilar. A total of 515 participants (90.8%) completed the study, with similar proportions of participants in the biosimilar group (91.2%) and originator group (90.5%).1
The mean age of the cohort was 60.8 years, the mean weight was 98.1 kg (216.3 lb), and most participants were male (60.1%) and Caucasian (79.7%). Demographic characteristics such as age, gender, ethnicity, and BMI were well matched between the two groups, and the researchers noted that mean baseline levels of HbA1c were also similar between treatment groups.1
Researchers observed a similar proportion of participants in both the biosimilar (19.2%) and reference treatment groups (21.3%) who tested positive for treatment-induced anti-insulin antibodies. (90% CI, -7.6% to 3.5%). In each subgroup, a similar proportion of participants developed treatment-induced anti-insulin antibodies. This included participants who had been previously exposed to insulin glargine (9.5% for biosimilar and 7.7% for reference) and participants who had not been previously exposed to insulin glargine (9.5% for biosimilar and 7.7% for reference). 20% for references and 21.9% for references). ), demonstrating equivalence of immunogenicity.1
The majority of participants in both groups had negative anti-insulin antibody status at baseline, and a similar proportion of these participants had a newly confirmed anti-insulin antibody response at week 26 (bio 16.9% for similar and 20.2% for reference). Furthermore, at week 26, researchers found that there was a least squares mean difference of 0.06% in change from baseline in HbA1c between the Basalin treatment group (-0.39%) and the Lantus treatment group (-0.45%). observed and confirmed their equivalence and non-inferiority of biosimilars. Based on predefined limits.1
The researchers found that the proportion of participants who achieved fasting blood glucose levels below 8.0 mmol/L at week 26 was similar between the biosimilar and reference groups (46.8% and 48.8%, respectively), and HbA1c levels They pointed out that the proportion of participants who reached . <7.0% (12.3% and 13.1%, respectively).1
Of note, the frequency and nature of treatment-emergent adverse events reported during the study were consistent with expectations and were similar between both groups (80.1% for the biosimilar and 81.6% for the reference). %). Hypoglycemia was the most commonly reported adverse event occurring during treatment, occurring in approximately half of participants in each treatment group.1
The researchers highlighted one potential limitation to the study, citing its open-label design. However, to reduce the risk of operational bias affecting study results, they noted that specific roles within the sponsor and research team will be maintained under blinding.1
“This study supports the bioequivalence of Vasaline and Lantus in terms of immunogenicity, safety, and efficacy in adult patients with type 2 diabetes. Pharmacokinetics and pharmacodynamics in patients with T1DM “Consistent with previous studies showing bioequivalence, this study provides further support for the bioequivalence of Vasaline and Lantus,” the researchers concluded.1
References:
- Christofides EA, Puente O, Norwood P, et al. Comparison of immunogenicity, efficacy, and safety of biofollow-on insulin glargine (Gan & Lee glargine) and originator insulin glargine (Lantus®) after 26 weeks of treatment in patients with type 2 diabetes: a randomized, open-label trial . Diabetes Obesity Meta Tab. 2024;1-10. doi:10.1111/dom.1556010
- Centers for Disease Control and Prevention. Type 2 diabetes. Diabetes mellitus. April 18, 2023. Accessed April 12, 2024. https://www.cdc.gov/diabetes/basics/type2.html
