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

Abasaglar® (insulin glargin): Farmakokinetik och Farmakodynamik

Den primära aminosyrasekvensen av Abasaglar och Lantus är identiska, och PK/PD-profilerna var liknande mellan grupperna i kliniska prövningar.

Detailed Information

The amino acid sequence of Abasaglar and Lantus is identical. The PK and PD profiles of Abasaglar and Lantus are similar.

Abasaglar and Lantus have an identical amino acid sequence.1-3

Despite amino acid sequences being identical between products, protein-based therapeutics manufactured by distinct processes do not necessarily have similar PK and PD profiles.4

Phase 1 pharmacokinetics and pharmacodynamics studies

Phase 1 studies were designed to test Abasaglar and Lantus against pre-defined acceptance limits that are standard in bioequivalence studies as defined by regulatory bodies.5 

Three single-site, randomized, double-blind, 2-treatment, 4-period, crossover, euglycemic clamp studies were conducted in healthy subjects to evaluate similarity in the PK and PD of

  • Abasaglar

  • the US-approved version of Lantus, and

  • the EU-approved version of Lantus.5

The predefined criteria used to establish similarity of the PK and PD of Abasaglar and Lantus were met, thus the PK and PD were found to be similar between study groups.5

The median time to maximum effect of Abasaglar, measured by the peak rate of glucose infusion, was approximately 12 hours. The PD profile of Abasaglar following subcutaneous injection demonstrated sustained glucose lowering activity over 24 hours with no pronounced peak.1,5

References

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

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

3. 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

4. Tieu C, Lucas EJ, DePaola M, et al. Efficacy and safety of biosimilar insulins compared to their reference products: a systematic review. PLoS One. 2018;13(4):e0195012. http://dx.doi.org/10.1371/journal.pone.0195012

5. Linnebjerg H, Lam EC, Seger ME, et al. Comparison of the pharmacokinetics and pharmacodynamics of LY2963016 insulin glargine and EU- and US-approved versions of Lantus insulin glargine in healthy subjects: three randomized euglycemic clamp studies. Diabetes Care. 2015;38(12):2226-2233. http://dx.doi.org/10.2337/dc14-2623

Glossary

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

BG = blood glucose

EU = European Union

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

PD = pharmacodynamic

PK = pharmacokinetic  

SC = subcutaneous

Datum fӧr senaste ӧversyn 2018 M07 09

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