Abstract Number: PB0569
Meeting: ISTH 2020 Congress
Background: Recently three biosimilar/generic molecules of enoxaparin (Inhixa®, Gmemaxan® and Thorinane®) have been authorized by the European Medicines Agency (EMA), declared as identical to the reference product Clexane®, showing a good comparability in term of biological activity and chemical properties.
Aims: To compare in vitro anti-FXa activity of Inhixa® and Clexane® on normal plasma samples added with different amount of the two molecules.
Methods: Increasing amount of both LMWH were added to normal plasma pool to reach expected final concentration, ranging from 0 UI/ml up to 3.0 UI/ml, for a total of 8 different dilutions
(0 UI/ml, 0.125 UI/mL, 0.25 UI/mL, 0.5 UI/mL, 1.0 UI/mL, 1.5 UI/mL, 2.0 UI/mL, 3.0 UI/mL). Activated partial thromboplastin time (aPTT) and anti-FXa chromogenic assay were performed in duplicate, within 1 hour after sample preparation. Mean±standard deviation (SD), coefficient of variation (CV%) and linear regression analysis were calculated. Bland Altman method was used to evaluate bias between the two molecules.
Results: Clexane® and Inhixa® anti-Xa and aPTT ratio mean values were 0,84 UI/mL and 0,79 UI/mL and 1,81R and 1,76 R, respectively. Anti-FXa mean CV% between the two molecules was 5.45%, showing a costant small, but not significant, underestimation of Inhixa®. Bias between Clexane® and Inhixa® for anti-FXa assay and aPTT were 7,7% and 2,3% respectively. Coefficient of correlation (r) was > 0.999, both in the comparison of the two molecules and the expected values.
Conclusions: In vitro anti-FXa activity of Clexane® and Inhixa® showed very good correlations with a small underestimation of Inhixa®, lower than anti-FXa intra/inter assay variability. Limits are represented by the “in vitro” evaluation that cannot give any information respect “in vivo” pharmacokinetic, pharmakodynamic, clinical efficacy, safety and collateral effect as immunogenic reactivity. A strict pharmacovigilance should be recommended and anti-FXa monitoring, at least in particular clinical settings, should be advised.
aFXa UI/ml | aFXa UI/ml | aFXa UI/ml | aPTT (ratio) | aPTT (ratio) |
Expected final concentration | Clexane® | Inhixa® | Clexane® | Inhixa® |
3 | 2* | 2* | 3.14 | 2.95 |
2 | 1.83 | 1.71 | 2.24 | 2.21 |
1.5 | 1.41 | 1.34 | 1.99 | 1.93 |
1 | 0.98 | 0.94 | 1.68 | 1.65 |
0.5 | 0.49 | 0.44 | 1.36 | 1.35 |
0.25 | 0.24 | 0.23 | 1.19 | 1.17 |
0.125 | 0.14 | 0.12 | 1.07 | 1.06 |
[Tab1. Comparison between anti-FXa activity, aPTT and expected results, using the two molecules *Upper limit of detection]
To cite this abstract in AMA style:
Dellanoce C, Paoletti O, Tala M, Cancelli V, Cancellieri E, Morandini R, Zambelli S, Beati MC, Stramezzi M, Castellani V, Testa S. Biosimilar Enoxaparin Sodium Inhixa® Compared with Clexane®: An in vitro Study [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/biosimilar-enoxaparin-sodium-inhixa-compared-with-clexane-an-in-vitro-study/. Accessed November 30, 2023.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/biosimilar-enoxaparin-sodium-inhixa-compared-with-clexane-an-in-vitro-study/