Until recently, non-biological complex drugs (NBCDs) such as iron-carbohydrates, liposomal drugs and the glatiramoids, were approved under the generics pathway. However, unlike small molecule drugs, which are considered therapeutically equivalent, there are various discussions that follow-on NBCDs are not therapeutically equivalent and may have a different tolerability profile.
Like proteins, NBCDs can be difficult or impossible to completely characterize, have multiple modes of therapeutic activity, and rely on a well-controlled manufacturing process to ensure drug identity and quality. Some complex drugs have unknown mechanism of action. Because NBCDs are not fully to be characterized in vitro it is not known what clinical meaningful differences could be induced by the difficult to control, mostly proprietary manufacturing process. NBCDs present a great challenge to both the scientific community and regulatory agencies.
FDA and EMA have issued several draft guidance documents or reflection papers of nanomedicines nature like liposomes or iron carbohydrates, which may proceed with new guidelines for future approvals.
This Special Issue provides in-depth scientific knowledge on the complexity of NBCDs and the subsequent clinical implications in interchange and substitution of these medicinal products, as well as the safety and efficacy issues of NBCDs from a patient’s perspective.
Current regulatory pathways for NBCDs in the US and EU as well as nanomedicines will also be discussed in this Special Issue.
Guest Editor: Professor Gerrit Borchard, Professor of Biopharmaceutical Sciences, University of Geneva, Switzerland
For further information on the editorial topics, please contact the Publisher.
Source URL: http://gabi-journal.net/about-gabi/current-activities/educational-series/non-biological-complex-drugs
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