Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Hur kan Abasaglar® (insulin glargin) jämföras med Lantus?

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

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Description and Indication

Abasaglar and Lantus have the same indication and limitations of use.1,2

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

Information from the Label of products are presented in Description and Indication of Abasaglar and Lantus.1,2

Description and Indication of Abasaglar and Lantus1,2

   

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.

ELEMENT Clinical Studies

ELEMENT 1 and ELEMENT 2 were phase 3 studies that assessed the efficacy and safety of Abasaglar compared with Lantus in patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM).3,4

At week 24, treatment with Abasaglar provided a mean reduction in glycated hemoglobin (HbA1c) that was noninferior to that achieved with Lantus.3,4

Abasaglar has a similar efficacy and safety profile to Lantus in patients with T1DM and T2DM.3-5

References

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

2Lantus [summary of product characteristics]. Sanofi-Aventis Deutschland GmbH, Germany.

3Blevins 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. https://doi.org/10.1111/dom.12496

4Rosenstock 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. https://doi.org/10.1111/dom.12482

5Ilag 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

Datum fӧr senaste ӧversyn 2020 M01 29


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