Iron carbohydrate follow-on NBCDs

Fármacos complejos no biológicos/Informes | Posted 12/08/2016 post-comment0 Post your comment

Follow-on versions of iron–carbohydrate non-biological complex drugs (NBCDs) was a subject discussed at the International Symposium on the Scientific and Regulatory Advances in Complex Drugs, which took place in Budapest, Hungary on 27-28 October 2014 [1].

NBCD ASEAN V16F09BF S61 V16F20JM

Iron–carbohydrate colloids are:
1. non-biological complex drugs;
2. carbohydrate coated polynuclear iron(III)-oxo-hydroxide cores with an unknown structure;
3. nanosized dispersions;
4. pro-drugs: highly reactive active Fe3+ to be released in a controlled manner upon administration;
5. the result of laborious, tightly controlled manufacturing processes.

Iron carbohydrate complexes are made out of different mono- or polymeric ‘sugars’, such as sucrose, gluconate, dextran, carboxymaltose, isomaltoside or polyglucosesorbitol, which stabilize the polynuclear oxyhydroxy core and affect the kinetics and (dose) tolerance of the product.

Some follow-on versions of iron-carbohydrate NBCDs have been authorized via the generics regulatory pathway (national route/decentralized procedure) without considering the consequences of their complex, colloidal/nanoparticulate structure. This is somewhat worrying when considering evidence from clinical settings, which has shown an increase in adverse drug reactions and a reduction in the efficacy of the follow-on product.

The European Medicines Agency (EMA) has issued a reflection paper for follow-on versions of iron-based nano-colloidal products in which it explains the additional data requirements for such products [2].

The approval of follow-on iron carbohydrate NBCDs (dextran derivatives) in Sweden has called into question approval on the national level, especially considering that a referral process to EMA was initiated in 2013 by the French regulatory agency for all intravenous iron products.

Conflict of interest
The authors of the conference report [1] did not provide any conflict of interest statement.

Editor’s comment
Readers interested to learn more about follow-on Iron carbohydrate NBCDs are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Retrospective chart review: disrupted anaemia control in haemodialysis patients following the switch to an iron sucrose similar (ISS) after long-term treatment with the originator iron sucrose (IS)

If you are interested in contributing a research manuscript in a similar area to the GaBI Journal, please send us your submission here.

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Status and regulatory issues surrounding follow-on NBCDs

References
1. Crommelin DJ, et al. The similarity question for biologicals and non-biological complex drugs. Eur J Pharm Sci. 2015 Aug 30;76:10-7.
2. GaBI Online - Generics and Biosimilars Initiative. EMA issues reflection paper for follow-on versions of iron-based nano-colloidal products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 12]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/Guidelines/EMA-issues-reflection-paper-for-follow-on-versions-of-iron-based-nano-colloidal-products

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