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Biosimilar Enoxaparin Sodium Inhixa® Compared with Clexane®: An in vitro Study

C. Dellanoce1, O. Paoletti2, M. Tala2, V. Cancelli2, E. Cancellieri2, R. Morandini2, S. Zambelli2, M.C. Beati2, M. Stramezzi2, V. Castellani2, S. Testa2

1ASST Cremona, Cremona, Italy, 2ASST Cremona, Department of Laboratory Medicine, Cremona, Italy

Abstract Number: PB0569

Meeting: ISTH 2020 Congress

Theme: Diagnostics and OMICs » Laboratory Diagnostics

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.

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