Eli Lilly and Boehringer Ingelheim’s Lantus biosimilar shows similar efficacy and safety

June 17, 2014 11:38 AM

Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals Inc. this week presented data showing that LY2963016, the alliance’s investigational new insulin glargine product, has a similar safety and efficacy profile to currently marketed insulin glargine (Lantus®).

Results from these Phase I and Phase III studies were presented at the 74th American Diabetes Association Scientific Sessions in San Francisco.

“Results from six completed clinical trials for this new insulin glargine product showed that it works similarly in the body and produces clinical results similar to Lantus,” said Tom Blevins, M.D., endocrinologist with Texas Diabetes & Endocrinology, Austin, TX. “These data are important because Lilly/BI’s insulin glargine could serve as an important treatment option in the future when physicians are deciding on an insulin glargine product to help patients meet their treatment goals.”

LY2963016 insulin glargine is an investigational basal insulin that is intended to provide long-lasting blood sugar control between meals and at night, an integral part of glycemic control. It has the same amino acid sequence as Lantus and, in most geographic regions, will be submitted for approval as a biosimilar. As the term ‘biosimilar’ is a regulatory designation, LY2963016 insulin glargine is considered a biosimilar in some regions but not in others, including the United States.

“Lilly and BI are pleased to share our new insulin glargine data with the medical community,” said Gwen Krivi, Ph.D., vice president, Lilly Diabetes Development. “Our LY2963016 insulin glargine data package has been submitted for review to several global regulatory agencies, including the U.S., Europe and Japan.  This is one step closer to providing an important insulin glargine option to physicians and patients.”

Phase III Study Results
In patients with type 1 and type 2 diabetes, LY2963016 insulin glargine was compared to currently marketed insulin glargine, and both products led to significant decreases in average blood glucose levels (HbA1c). LY2963016 insulin glargine demonstrated non-inferiority compared to marketed insulin glargine, and marketed insulin glargine demonstrated non-inferiority to LY2963016 insulin glargine.

  • Patients with type 1 diabetes had HbA1c reductions of -0.4 percent (LY2963016 insulin glargine) and -0.5 percent (marketed insulin glargine) at 24 weeks, with similar results at 52 weeks (-0.3 percent for both insulin glargine treatments).
  • Patients with type 2 diabetes had HbA1c reductions of -1.3 percent in both insulin glargine treatment groups at 24 weeks.

Approximately one-third of patients with type 1 diabetes reached target HbA1c levels of less than 7 percent at 24 weeks with LY2963016 insulin glargine (35 percent) and marketed insulin glargine (32 percent) treatment. In patients with type 2 diabetes, about half of patients reached these target levels with LY2963016 insulin glargine (49 percent) and marketed insulin glargine (53 percent) treatment.

In patients with type 1 diabetes, the incidence of adverse events at 52 weeks was the same between the two insulin treatments (62 percent). The total average hypoglycemia rate (having symptoms attributable to a low blood sugar level and/or blood glucose less than or equal to 70 mg/dL) at 24 weeks was also similar between LY2963016 insulin glargine and marketed insulin glargine (87 and 89 events/patient/year, respectively).

The frequency of adverse events was similar between the two treatments in patients with type 2 diabetes (52 percent and 48 percent, LY2963016 insulin glargine and marketed insulin glargine, respectively), including the total average hypoglycemia rate (21 vs. 22 events/patient/year, LY2963016 insulin glargine and marketed insulin glargine, respectively).

The Phase III studies also evaluated whether LY2963016 insulin glargine and marketed insulin glargine led to similar development of insulin antibodies and similar effects of immune responses on clinical outcomes. Results showed a similar immunogenicity profile of LY2963016 insulin glargine to marketed insulin glargine.

Phase I Study Results
Results from Phase I studies showed that LY2963016 insulin glargine and marketed insulin glargine have similar pharmacokinetic (PK) and pharmacodynamic (PD) profiles, meaning that LY2963016 insulin glargine, when injected under the skin, provided similar amounts of insulin in the blood, with similar characteristics and insulin action (how insulin works to control blood glucose levels), compared to marketed insulin glargine.

In these Phase I studies, LY2963016 insulin glargine was well-tolerated, with no safety concerns noted in adverse events, clinical laboratory tests, vital signs or ECG data. The frequency of adverse events reported was similar between the two treatments.

A further Phase 1 study assessed LY2963016 insulin glargine’s duration of action (how long the insulin works to control blood glucose levels) in patients with type 1 diabetes. Results showed that the average duration of action was 24 and 26 hours for LY2963016 insulin glargine and marketed insulin glargine, respectively. LY2963016 insulin glargine was well-tolerated, with no safety concerns noted in adverse events, clinical laboratory tests, vital signs or ECG data. The frequency of adverse events reported was similar between the two treatments.

 

Source: Eli Lilly press release

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