Non Biologic Complex Drug Concept: Experiences with Iron Sucrose and LowMolecular Weight Heparin
2014
When the patent of a small molecule drug expires, generics may be introduced. They are considered
therapeutically equivalent once pharmaceutical equivalence (i.e. identical active substances) and bioequivalence
(i.e. comparable pharmacokinetics) have been established in cross-over volunteer study. However this generic
paradigm cannot be applied to complex drugs as biologics. For copies of biologics EMA, and FDA, have introduced
a new regulatory bio-similar pathway which mandate clinical trials to show therapeutic equivalence. However for
some complex drugs, such as iron-carbohydrate drugs, low molecular weight heparins (named Non Biologic
Complex Drugs [NBCD]), regulatory guidance is still mostly lacking. In this paper we will discuss therapeutic
experiences with these different classes of complex drugs and their specificity, to provide scientific arguments for
consideration for a new regulatory framework.
Keywords:
- Correction
- Source
- Cite
- Save
- Machine Reading By IdeaReader
26
References
1
Citations
NaN
KQI