Biotech Values

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Some of the generic versions of LMWHs are already available in Asia and South America and represent substandard products. These products do not conform to current product and regulatory compliance guidelines. For this reason some of the generic LMWHs manufactured in South Asia have been removed from the market. Moreover, there are no established guidelines to approve or disapprove these drugs in Europe or the US. Therefore, additional guidelines regarding the characterization of these products may be needed, and any unilateral claim from manufacturers that structural information obtained from specific analytical profiling may result in an ideal generic product is not valid. Claims from the suppliers that generic LMWHs are identical to branded products are not supported by any publication or other documentation that we are aware of at this time. Chemical characterization of a complex heterogeneous sulfated carbohydrate mixture may be similar; however, the pharmacodynamics of such a mixture is a cumulative biologic response. Until data on pharmacodynamics are available, the product(s) cannot be claimed similar. Therefore in addition to the chemical characterization, molecular profiling of these drugs may be necessary.

above is an excerpt from:
Generic Low Molecular Weight Heparins: Where Do We Stand?

http://www.natfonline.org/graphics/LMWHs_July2007.pdf