Bioequivalence of generic and branded subcutaneous enoxaparin: A single-dose, randomized-sequence, open-label, two-period crossover study in healthy Chinese male subjects

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

“…In contrast, when only simple anti-FXa and anti-FIIa activities were evaluated no differences in activities were found [30,31]. Because aPTT inhibition by LMWHs is less sensitive compared with factor (F) Xa inhibition and the assay shows a high variability, it was therefore eliminated from the present recommendations.…”

Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes

“…One in vitro study found structural variability but similar biological activities between brand and generic versions [27]. The remaining studies found that bioequivalence was met for the generic version [28][29][30].…”

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.…”