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Health authorities, such as EMEA and leading international medical societies consider these drug products to have specific manufacturing process leading to unique biochemical, pharmacological and clinical profiles and to be distinct and not clinically interchangeable.

 

“The heterogeneity of LMWH is very high, the mode of action is not completely understood and it is uncertain whether the PD markers are representative for the clinical outcome. Thus, the major burden of demonstrating two LMWHs being similar biological medicinal products is on a clinical trial.”

 

“Biosimilar LMWHs may raise some concerns relative to the presence of inactive, uncharacterized, less and/or more active moieties not found in the originator products. Differences between the biochemical and biological activities of biosimilar and originator may have significant clinical consequences.”

 

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