Regulations for follow-on NBCDs

Fármacos complejos no biológicos/Informes | Posted 13/11/2015 post-comment

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Regulations for follow-on versions of non-biological complex drugs (NBCDs) in Europe and the US were 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].

The European Medicines Agency (EMA) has recognized the complications associated with approval of originator NBCDs and has in the past therefore requested extra information to support follow-on NBCDs on a case-by-case basis.

EMA has also issued reflection papers outlining the extra data required for approval of follow-on versions of iron-based nano-colloidal products [2] and intravenous liposomal products [3]. The agency has not, however, formally classified certain product families, e.g. glatiramoids, liposomes or iron carbohydrates, as NBCDs. But, nanomedicines are often mentioned in the context of NBCDs.

EMA tends to refer to biosimilars regulations when considering follow-on NBCDs. However, one major difference is the fact that follow-on NBCDs may receive marketing approval through the decentralized route, unlike biosimilars, which must follow the centralized procedure [4].

The US Food and Drug Administration does not formerly recognize NBCDs, with originators required to follow the new drug application route and follow-on NBCDs using the generics – abbreviated new drug application – route. The agency has, however, issued draft guidance documents for certain NBCDs, e.g. liposomes, different iron carbohydrates (iron sucrose, iron gluconate, ferumoxytol) and cyclosporine ophthalmic emulsions.

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 NBCDs are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead?

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

Related articles
Iron carbohydrate follow-on NBCDs

Glatiramoid follow-on NBCDs

Liposomal follow-on NBCDs

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;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 2015 Nov 13]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/Guidelines/EMA-issues-reflection-paper-for-follow-on-versions-of-iron-based-nano-colloidal-products
3. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for follow-on NBCDs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 13].
4. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 13]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars

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