Chinese Study Finds Patients Taking Reference Insulin Glargine Had Better Glycemic Control

While a study in healthy volunteers demonstrated bioequivalence of the 2 insulin products, to date, few direct comparisons of the biosimilar and the innovator have been available. A new study compared the efficacy and safety of treatment with each of the products in a retrospective analysis of hospitalized patients with type 2 diabetes and found that the reference insulin provided better fasting glycemic control than the biosimilar.
Kelly Davio
May 02, 2019
Currently, 2 insulin glargine products are available in China: Sanofi’s innovator drug, Lantus, and a biosimilar produced by Gan and Lee that is sold under the name Basalin. While a study in healthy volunteers demonstrated bioequivalence of the 2 insulin products, to date, few direct comparisons of the biosimilar and the innovator have been available. A new study compared the efficacy and safety of treatment with each of the products in a retrospective analysis of hospitalized patients with type 2 diabetes and found that the reference insulin provided better fasting glycemic control than the biosimilar.

The study used electronic medical records for patients who were hospitalized in noncritical settings at a single center in China between 2006 and 2017. The patients were admitted primarily as a result of uncontrolled hyperglycemia. Patients were treated with subcutaneous injection of basal insulin, together with or without mealtime insulin or oral antihyperglycemic drugs.

Whether patients received the biosimilar or the reference insulin glargine depended on insurance coverage, affordability, and patient access after discharge.

In total, 47 patients received the biosimilar and 429 received the reference. Propensity score matching was conducted to minimize selection biases that could confound comparisons between basal insulin treatments. Before matching, there were marked differences between groups in terms of duration of diabetes and the proportion of male patients. After matching, 34 patients who received the biosimilar and 101 patients who used the reference were considered.

In the matched group, patients who received the reference had a significantly greater mean reduction in fasting blood glucose (−2.20 mmol/L) than those who received the biosimilar (−1.24 mmol/L; P  = .04). The mean fasting blood glucose value was also numerically lower for patients treated with the reference (7.26 mmol/L) than with the biosimilar (8.20 mmol/L; P  = .12).

Patients receiving the reference tended to have lower mean postbreakfast and prelunch blood glucose levels compared with those receiving the biosimilar, but this trend did not reach statistical significance.

The incidence of hypoglycemia was low and comparable between groups.

The authors note that the study was limited by the short duration of treatment and the single-center setting. Further investigations should include a randomized controlled trial to investigate whether changes to treatment practice favoring the reference insulin glargine can be recommended.

Basalin, the biosimilar considered in this study, is not yet approved in the United States. However, according to a December 2018 agreement, Gan and Lee’s insulin products will be commercialized by biosimilar developer Sandoz in the European Union, United States, Switzerland, Japan, South Korea, Canada, Australia, and New Zealand. 

Reference
Hu X, Zhang L, Dong C, Dong Y, Jiang J, Gao W. A propensity score matched comparison of brand and biosimilar basal insulin in non-critical hospitalized patients with type 2 diabetes mellitus [published online March 21, 2019]. Adv Ther. doi: 10.1007/s12325-019-00922-9.

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