The FINANCIAL — Data from secondary analyses of Phase III clinical trials showed that ABASAGLAR (insulin glargine), Eli Lilly and Company and Boehringer Ingelheim’s biosimilar insulin glargine, demonstrated safety and efficacy outcomes similar to Lantus insulin glargine in patients with type 1 and type 2 diabetes who received pre-study treatment with Lantus. These data were presented today at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting in Stockholm, Sweden.
The subgroup of patients previously treated with Lantus had significant reductions in average blood glucose levels (HbA1c) from baseline when they were randomised to either ABASAGLAR or Lantus. Similar to the total study population, the analyses showed no significant differences in HbA1c reduction from baseline to 52 weeks in type 1 patients (-0.28 percent vs. -0.26 percent) and to 24 weeks in type 2 patients (-1.02 percent vs. -1.01 percent) with ABASAGLAR and Lantus treatment, respectively, according to Boehringer Ingelheim.
Results also showed no significant differences between the two treatments in key secondary efficacy and safety measures, including percentage of patients reaching target HbA1c levels, total and nocturnal hypoglycaemia rates and incidence of treatment-related adverse events. Statistical differences were seen in weight change, incidence of detectable antibodies and incidence of serious adverse events; however, these differences were not observed in the total study populations. Further, these results were not consistently observed across both studies and did not indicate any clinically meaningful treatment differences.
“These secondary analyses are important because they provide additional perspectives on how ABASAGLAR works in people with diabetes, regardless of prior insulin glargine treatment,” said David Kendall, MD, vice president, Medical Affairs, Lilly Diabetes. “These data provide important additional evidence for the similarity of ABASAGLAR to Lantus in people with type 1 and type 2 diabetes and provide physicians further information on this new treatment option.”
ABASAGLAR® was first granted approval by the European Commission in September 2014, marking the first biosimilar insulin approval in the European Union. As of September 2015, ABASAGLAR has been commercially launched in several countries including Germany, United Kingdom, Estonia, the Czech Republic, Slovakia and Japan. It will launch in other markets throughout the remainder of 2015 and thereafter. Globally, Lilly and Boehringer Ingelheim refer to their insulin glargine product as Basaglar, which will be the trade name in many regions across the world. In Europe, the product is referred to as ABASAGLAR.
Manufacturing biological medicines is a complex process, and expertise is needed for consistent product quality. Lilly and Boehringer Ingelheim have extensive expertise, insights and knowledge, which enable them to provide high-quality medicines to help meet the needs of people with diabetes around the world.
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