SASAT (South Asian Society on Atherosclerosis & Thrombosis) Proposal for Regulatory Guidelines for Generic Low-molecular Weight Heparins (LMWHs)

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

“…Clinical trials including VTE prophylaxis in high-risk patients or arterial thromboembolism with efficacy and safety end points are common recommendations to all documents, from European Medicines Agency (EMEA), to International Society on Thrombosis & Haemostasis (ISTH) and South Asian Society on Atherosclerosis and Thrombosis (SASAT). 13,21 Our study is the first to address those recommendations. There are some weaknesses in the study.…”

“…1,4,12 New guidelines regarding the use of generic LMWHs are now under development. 13 The trend to use only pharmacokinetic and pharmacodynamic parameters for regulatory approval is spreading worldwide including large countries like China. 14 As the primary aim of a generic drug is to reduce costs without compromising patient care, it is expected that thorough studies are performed before regulatory approval.…”

General, Vascular, Bariatric, and Plastic Surgical Patients

“…Therapeutic interchange among these products is not appropriate. 99 In a recent double-blind, double-dummy randomized study in 2927 patients having high-risk major abdominal surgery, fondaparinux 2.5 mg once daily was found to be at least as effective as perioperative LMWH (dalteparin 5000 U daily) in preventing venographically detected DVT without any increase in bleeding. 100 The incidence of DVT was 6.1% in the dalteparin group and 4.6% in the fondaparinux group (P ¼ .14).…”

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

“…Many recommendations for the development and use of biosimilar LMWHs have been published. A summary of these recommendations is presented by the International Society on Thrombosis and Haemostasis, The North American Thrombosis Forum, The Scientific Committee of the International Union of Angiology, South Asian Society of Artherosclerosis and Thrombosis, The American Society of Chest Physicians, The Society of Hospital Medicine, the American Pharmacists Association, American College of Cardiology, American Health Association, Austrian Society of Hematology and Oncology, and the Italian Society for Haemostasis and Thrombosis …”