Biosimilar of Humalog Shows Non-Inferiority in Type 1 Diabetes

Novel diabetes biosimilar shows similar safety, efficacy, and immunogenicity to the reference drug.

A biosimilar of Humalog (insulin lispro; Ly-Lis) was found to be comparable to the brand name drug, according to a study published in Diabetes Technology & Therapeutics.

The randomized, open-label phase 3 SORELLA 1 trial aimed to demonstrate similar safety, efficacy, and immunogenicity of SAR342434 (SAR-Lis) versus Ly-Lis in adult patients with type 1 diabetes treated with multiple daily injections while using Lantus.

Ly-Lis is a fast-acting human insulin analog used to lower blood glucose. It is usually injected within 15 minutes before a meal or immediately after.

A total of 507 patients were included in the study, completing the 6-month trial and continuing with SAR-Lis or Ly-Lis in a randomized 6-month extension.

The investigators evaluated changes in HbA1c, fasting plasma glucose, 7-point self-monitored plasma glucose profiles, hypoglycemic events, treatment-emergent adverse events (AEs), and anti-insulin antibodies.

The results of the study showed the least square mean change in HbA1c was similar in both treatment groups.

Non-inferiority at prespecified 0.3% non-inferiority margin and inverse non-inferiority was demonstrated, according to the report.

A small increase in HbA1c was observed in both groups at week 52 versus week 26. Similarities in fasting plasma glucose and 7-point self-monitored plasma glucose profiles were observed between groups.

The investigators also observed similar changes in mean daily mealtime and basal insulin doses at week 52.

No difference in hypoglycemia, treatment-emergent AEs, and anti-insulin antibodies were observed.

The most common AEs were hypersensitivity events and injection site reactions.

Limitations to the study included the population—–which was largely adult white Caucasian––and the open label design, according to the authors. Although SAR-Lis demonstrated similar safety, efficacy, and tolerability in Black, Asian, and Hispanic patients with type 1 diabetes for 6 months, the subgroups had low numbers of patients. The authors warn the results for this subgroup should be interpreted with caution.

Biosimilar insulins, including rapid-acting insulins, may have the potential to reduce diabetes treatment costs, increase the accessibility of insulin treatment, and expand the number of insulin brands available for those with diabetes,” the authors wrote. “To the best of our knowledge we report the first study evaluating long-term use of a biosimilar rapid-acting insulin (insulin lispro) analog in patients with type 1 diabetes.”

An estimated 30.3 million individuals in the United States were living with diabetes in 2015 and approximately 1.5 million Americans are newly diagnosed each year, according to the American Diabetes Association. In 2012, the total cost of diagnosed diabetes in the United States was $245 billion.