Differences of Present Recommendations and Guidelines for Generic Low-Molecular-Weight Heparins: Is There Room for Harmonization

2011 ◽  
Vol 17 (6) ◽  
pp. E158-E164 ◽  
Author(s):  
Job Harenberg
Keyword(s):  
Molecular Weight ◽  
Patent Protection ◽  
European Medicines Agency ◽  
Low Molecular Weight ◽  
Low Molecular Weight Heparins ◽  
The North ◽  
Scientific Organizations ◽  
Set Up ◽  
Medical Indications

Based on the results of large clinical trials, several low-molecular-weight heparins (LMWHs) have been approved for prophylaxis and the treatment of venous and arterial thromboembolism. As a result of expiration or pending expiration of patent protection of the originator LMWHs, the first generic LMWH enoxaparin has been approved by the Food and Drug Administration for clinical use in all medical indications. The European Medicines Agency has set up guidelines for the production of generic LMWHs. The International Society of Thrombosis, the North American Thrombosis Forum and other scientific organizations raised concerns regarding the safety of generic LMWHs due to economic reasons. These organizations have published statements for the production of generic LMWHs to ensure the quality of the products and the safety for patients. Ideally, the differences between the actual recommendations and guidelines for the production of generic version of LMWHs should be harmonized.

scholarly journals Structural and Functional Characterization of Low-molecular-weight Heparins: Impact on the Development of Guidelines for Generic Products

2009 ◽  
Vol 15 (2) ◽  
pp. 137-144 ◽  
Author(s):  
Cafer Adiguzel ◽  
Walter P. Jeske ◽  
Debra Hoppensteadt ◽  
Jeanine M. Walenga ◽  
Vinod Bansal ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Functional Characterization ◽  
Current Data ◽  
European Medicines Agency ◽  
Low Molecular Weight ◽  
Low Molecular Weight Heparins ◽  
Biological Drugs ◽  
Biologic Drugs ◽  
The Us ◽  
Us Fda

Low-molecular-weight heparins (LMWHs) are poly-pharmacologic drugs used to treat thrombotic and cardiovascular disorders. Recently, several generic versions of branded LMWHs have been introduced. Although generic versions of LMWHs exhibit similar profiles, marked differences in their biological and pharmacologic properties have been demonstrated. Several studies have demonstrated differences in terms of anti-Xa activity and tissue factor pathway inhibitor release. The current data emphasize the need to consider multiple functional parameters when defining bioequivalence of biologic drugs and also underscore the importance of further pharmacologic studies involving animal and human clinical trials. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are currently developing guidelines for the acceptance of complex biological drugs including LMWHs. The US FDA considers these drugs as follow-on agents whereas the EMEA classifies these drugs as biosimilar agents. Until clear guidelines are developed, generic interchange of LMWHs may not be feasible.

Thromboprophylaxis with Low-Molecular-Weight Heparins: An Assessment of the Methodological Quality of Studies

2015 ◽  
Vol 41 (02) ◽  
pp. 113-132 ◽  
Author(s):  
Giancarlo Agnelli ◽  
Paolo Prandoni ◽  
Giovanni Di Minno ◽  
Francesco Scaglione ◽  
Patrizia Boracchi ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Methodological Quality ◽  
Low Molecular Weight ◽  
Low Molecular Weight Heparins

A Perspective on Low Molecular Weight Heparins in the Management of Thrombosis

1993 ◽  
Vol 13 (S 01) ◽  
pp. S5-S11 ◽  
Author(s):  
Debra Hoppensteadt ◽  
Jeanine Walenga ◽  
A Ahsan ◽  
O Iqbal ◽  
W Jeske ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Mechanism Of Action ◽  
Manufacturing Process ◽  
Laboratory Tests ◽  
Low Molecular Weight ◽  
Low Molecular Weight Heparins ◽  
Pharmacological Management

SummaryThe introduction of low molecular weight heparins has added a new dimension to the pharmacological management of thrombotic disorders. Because of different chemical and pharmacological characteristics, due to the manufacturing process, each LMWH should be considered as a distinct entitity and only be used for its given indication. A list of commercially available LMWHs is included. The mechanism of action of the LMWHs and their use in various disorders are discussed. Available laboratory tests for monitoring LMWHs are presented and their limitations pointed out.

The Rotterdam Initiative in Reducing Waste Discharges at Source

1991 ◽  
Vol 24 (10) ◽  
pp. 171-177
Author(s):  
T. Vellinga ◽  
J. P. J. Nijssen
Keyword(s):  
Public Relations ◽  
Action Plan ◽  
Detailed Balance ◽  
River Rhine ◽  
The North ◽  
Complementary Role ◽  
Action Programme ◽  
The North Sea ◽  
Set Up

Much of the material dredged from the port of Rotterdam is contaminated to such a degree that it must be placed in specially constructed sites. The aim of Rotterdam is to ensure that the dredged material will once again be clean. This will entail the thorough cleansing of the sources of the contamination of the sediment in the harbours and in the River Rhine. The Rotterdam Rhine Research Project (RRP) is one of the means to achieve this based on: technical research, legal research, public relations and dialogues with dischargers. The programme for five selected heavy metals is almost complete. For many heavy metal discharge points between Rotterdam and Rheinfelden, a specially devised independent load assessment has been carried out four times. Balance studies were used to determine the relative contributions of the point discharges to the total. Currently the results are being used in an attempt to negotiate agreements with a selected number of the major dischargers. At present, more detailed balance studies are being set up and exploratory measurements carried out for organic micropollutants. It may be concluded that the research is progressing successfully and methods and techniques developed seem satisfactory and broadly applicable. The Rhine Action Programme encompasses an international effort to improve the quality of the Rhine water. Although the RRP plays a modest complementary role to the Rhine Action Plan, there is no doubt of the value of this Rotterdam initiative. The mode of work followed in the RRP contains elements that can be of use in combatting the contamination of the North Sea by rivers other than the Rhine.

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