Status and outstanding regulatory issues for follow-on versions of non-biological complex drugs (NBCDs) 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 key attributes of NBCDs are defined as:
1. Consisting of a complex multitude of closely related structures
2. The entire multitude is the active pharmaceutical ingredient
3. The properties cannot be fully characterized by physicochemical analysis; and
4. The consistent, tightly controlled manufacturing process is fundamental to reproduce the product
NBCDs encompass product families such as glatiramoids, liposomes, iron-carbohydrate colloids, polymeric micelles, swelling polymers, albumin-cytostatic complexes and other nanomedicines.
Currently, follow-on versions of NBCDs are approved under the generics pathway [1]. However, presenters at the conference suggested that following the main principles of regulatory pathways for biologicals (with appropriate product-by-product adjustments), instead of that for small molecules, would perhaps be the more logical strategy for these NBCDs. Others, however, advocate the need for separate, specific guidelines for these products.
In the following series of four articles the issues related to NBCDs are presented.
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:
Non-Biological Complex Drugs (NBCDs) and their follow on versions (generics): time for an editorial section
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
Regulations for 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. Guidelines needed for follow-on versions of NBCDs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 6]. Available from: www.gabionline.net/Reports/Guidelines-needed-for-follow-on-versions-of-NBCDs
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