A Comparison of the Biological Activity of 2 Formulations of Enoxaparin in 12 Healthy Volunteers

Abstract

After a single-dose injection in healthy participants, anti-Xa activities of 2 formulations of LMWH enoxaparin were comparable. No significant difference was observed in the mean plasma aPTT. It remains to be seen whether the 2 formulations would show comparable clinical efficacy.

Update of the recommendations on biosimilar low‐molecular‐weight heparins from the Scientific Subcommittee on Control of Anticoagulation of the International Society on Thrombosis and Haemostasis

“…Several recent pharmacodynamic investigations [28][29][30] reinforce the earlier recommendation of the Working Party of the SSC on Control of Anticoagulation of the ISTH [6] that Phase I clinical trials in human volunteers should be performed using a low prophylactic and a high therapeutic dose over 5-7 days each (Table S1). …”

“…In vitro studies have identified differing strength of activity for biological effects on various coagulation parameters between the originator and the biosimilar versions of LMWHs . In contrast, when only simple anti‐FXa and anti‐FIIa activities were evaluated no differences in activities were found .…”

Comparability of “Enoxamed” a Tunisian Generic Enoxaparin with the Originator Product: Non-clinical and Clinical Studies

“…The FDA approved the first copy of enoxaparin in 2010, using the expedited Abbreviated New Drug Application procedure proposed for requests for marketing authorization of small-molecule chemical drugs [3]. Several copies of enoxaparin are currently available worldwide and appeared in several countries such as China, India and Brazil [3][4][5]. Enoxamed ® is the second copy of enoxaparin approved in Tunisia [16].…”

“…Otherwise, enoxaparin experienced generic competition starting in 2010 [3]. In fact, generic versions of enoxaparin are available for clinical use in several countries [4,5]. However, the manufacturing process for biologics is complex which makes difficult to obtain exact replicas of the reference biologic.…”

Generic and Branded Enoxaparin Bioequivalence: A Clinical and Experimental Study

“…In the last decade, patent rights and supplementary protection certificates of branded enoxaparin have expired raising the opportunity to develop copies of this innovator product. As a consequence, generic enoxaparin appeared on the market in many countries such as China, India and Brazil [6][7][8]. Similarly, a new generic enoxaparin was recently proposed in Tunisia.…”