Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

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Abasaglar® (insulin glargin): Jämförelse med Lantus

Kliniska studier har rapporterat liknande effekt och säkerhet mellan Abasaglar och Lantus.

Detailed information

Abasaglar is approved as a biosimilar in the European Union.1

Abasaglar and Lantus have an identical amino acid sequence.2

Abasaglar and Lantus have the same indication and limitations of use (Table 1).1,3

Phase 3 clinical studies in patients with T1DM or T2DM have shown that Abasaglar has a similar efficacy to Lantus in lowering HbA1c, as well as a similar safety profile.2,4,5

Table 1. Description and Indication of Abasaglar and Lantus1,3

   

Abasaglar

Lantus

Active ingredient

insulin glargine

insulin glargine

Concentration

100 units/mL

100 units/mL

Manufacturer

Eli Lilly and Company

Sanofi-Aventis

Indication

Treatment of DM in adults, adolescents. and children aged 2 years and above

Treatment of DM in adults, adolescents. and children aged 2 years and above

Limitations of use

Not recommended for treatment of DKA

Not recommended for treatment of DKA

Abbreviations: Abasaglar = Abasaglar® (insulin glargine) 100 units/mL; DKA = diabetic ketoacidosis; DM = diabetes mellitus; Lantus = Lantus® (insulin glargine) 100 units/mL.

References

1. Abasaglar [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Blevins TC, Dahl D, Rosenstock J, et al. Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus®) in patients with type 1 diabetes in a randomized controlled trial: the ELEMENT 1 study. Diabetes Obes Metab. 2015;17(8):726-733. http://dx.doi.org/10.1111/dom.12496

3. Lantus [summary of product characteristics]. Sanofi-Aventis Deutschland GmbH, Germany.

4. Rosenstock J, Hollander P, Bhargava A, et al. Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus®) in patients with type 2 diabetes who were insulin-naïve or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study). Diabetes Obes Metab. 2015;17(8):734-741. http://dx.doi.org/10.1111/dom.12482

5. Ilag LL, Deeg MA, Costigan T, et al. Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus® insulin glargine in patients with type 1 or type 2 diabetes mellitus. Diabetes Obes Metab. 2016;18(2):159-168. http://dx.doi.org/10.1111/dom.12584

Glossary

Abasaglar = Abasaglar® (insulin glargine) 100 units/mL

HbA1c = glycated hemoglobin

Lantus = Lantus® (insulin glargine) 100 units/mL

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2020 M01 29


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