No Difference in Quality of Glycemic Control With Biosimilar Versus Originator Insulin

An Asian study comparing the quality of glycemic control among patients using biosimilar insulin with those using originator insulin found no independent association of biosimilar insulin with differences in indicators of glycemic control—glycated hemoglobin (A1C), insulin dosage, or hypoglycemia.

Linsey Gani, MD, MPH, and colleagues with the Joint Asia Diabetes Evaluation (JADE) Collaborative Study Group carried out the analysis of over 81,500 patients throughout Asia with type 1 and type 2 diabetes who were enrolled in the JADE registry from 2007 to 2014. The study was published online March 25, 2018, in the Journal of Diabetes Investigation. The researchers believe their study is the first large-scale, cross-sectional survey on the use of biosimilar insulin in real-world practice.

The countries represented in the study were China, Hong Kong, India, Korea, the Philippines, Vietnam, Taiwan, Thailand, and Singapore. The study examined nearly 250,000 medication records for the prescriptions of 56,000 patients, 14,000 of which were classified as insulin. The insulin drugs were reviewed and classified into biosimilar or originator insulin; researchers recorded the insulin regimens used and total daily doses.

Biosimilar insulin was used in 4 countries: India, the Philippines, China, and Vietnam. The study found 16 biosimilar insulins to be used. Among insulin users in these countries, biosimilar insulin was prescribed to 7.1% of patients and originator insulin to 89.5%. The remaining 348 (3.4%) of patients were excluded from analysis due to uncertainty about the nature of their insulin.

India had the highest number of biosimilar insulin users (70.3%), followed by the Philippines (12.5%), China (8.6%), and Vietnam (8.3%). Among patients treated with biosimilar insulin, 58.4% were using premixed regimens, 20.6% were on basal-only regimens, 13.6% were on basal-plus or basal-bolus, and 1.8% were on bolus only.

Users of both originator and biosimilar insulin had similar distributions of type 1 diabetes and duration of disease. Both groups had similar proportions of patients who carried out blood glucose self-monitoring and adhered to a balanced diet.

Compared with users of originator insulins, patients using biosimilar insulins were younger, less likely to be college educated, and had higher body mass index, A1C, and insulin dose, and were more likely to receive diabetes education.

Biosimilar insulin users were less likely to attain A1C levels under 7.0%, report hypoglycemia, or receive concurrent non‐insulin antidiabetic drugs. Biosimilar‐insulin treated patients had a lower frequency of cardiovascular complications, and a higher proportion attained blood pressure and lipid targets. They were less likely to have retinopathy, but more likely to have microalbuminuria and peripheral neuropathy, the researchers reported.

The authors conclude that, although the quality of glycemic control was similar between biosimilar users and originator insulin users, more real-world data regarding patterns of biosimilar insulin usage and their independent associations with quality of glycemic control are required to truly inform practice and policy: “The large number of biosimilar insulins available in Asia calls for concerted efforts amongst policymakers, prescribers and payers to establish high-quality registers to monitor the safety and cost-effectiveness of these biosimilar insulins.”

Reference

Gani L, Lau E, Luk A, et al. Cross-sectional survey of biosimilar insulin utilization in Asia: the Joint Asia Diabetes Evaluation Program. [Published online March 25, 2018.] J Diabetes Investig. doi: 10.1111/jdi.12843.