alexa Non Biologic Complex Drug Concept: Experiences with Iron Sucrose and Low Molecular Weight Heparin
ISSN: 2165-7831

Journal of Blood & Lymph
Open Access

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Review Article

Non Biologic Complex Drug Concept: Experiences with Iron Sucrose and Low Molecular Weight Heparin

Jacques Rottembourg1* and Huub Schellekens2

1Department of Nephrology, Groupe Hospitalier Pitié-Salpêtrière- Paris, France

2Department of Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands

*Corresponding Author:
Jacques Rottembourg
Department of Nephrology
Groupe Hospitalier Pitié-Salpêtrière
83 Boulevard de l’Hôpital
75013 Paris, France
Tel: 0033143590821
Fax: 0033143590824
E-mail: [email protected]

Received Date: January 26, 2014; Accepted Date: March 06, 2014; Published Date: March 10, 2014

Citation: Rottembourg J, Schellekens H (2014) Non Biologic Complex Drug Concept: Experiences with Iron Sucrose and Low Molecular Weight Heparin. J Blood Lymph 4:123. doi:10.4172/2165-7831.1000123

Copyright: © 2014 Rottembourg J, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



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.


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