Generic Versus Branded Enoxaparin in the Prevention of Venous Thromboembolism Following Major Abdominal Surgery

Abstract

This exploratory trial suggests that the generic LMWH is probably as safe and as effective as the branded enoxaparin (Lovenox, Brazil) in the prophylaxis of VTE in this population.

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

“…The 2% incidence of venous thromboembolism in both groups was low and not different between the groups. Thus, no definite conclusions could be drawn from this small study [33]. For patients with unstable angina it was reported that the safety and efficacy of biosimilar LMWHs may not be equivalent to the originator versions even if equivalence was shown in another clinical setting as outcomes of clinical trials cannot be extrapolated between different patient populations [34][35][36].…”

Biosimilars of low molecular weight heparins: Relevant background information for your drug formulary

“…There was a difference in AHPF4 antibodies for the biosimilar, but the authors made no conclusions what should be the consequence of this finding . Another explorative trial with the same Brazilian enoxaparin in 200 patients with venous thromboembolism showed no difference in effect . The pharmacovigilance of biosimilars in the European has not yet lead to safety signals…”

“…28 Another explorative trial with the same Brazilian enoxaparin in 200 patients with venous thromboembolism showed no difference in effect. 29 The pharmacovigilance of biosimilars in the European has not yet lead to safety signals. 30 Specific attention on the occurrence of HIT should be a more prominent part of the discussion.…”

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

“…Among the enoxaparin studies (n = 9), the largest examining clinical outcomes compared Lovenox with a generic version produced by Eurofarma (the study was also funded by Eurofarma) [22]. Among the 200 post-surgical patients analyzed in a randomized, prospective fashion, the authors found no differences in clinical endpoints and laboratory measures of anticoagulant activity.…”