Defining and characterizing non-biological complex drugs (NBCDs) – Is size enough? The case for liposomal doxorubicin generics (‘liposomal nanosimilars’) for injection
Journal Title: Generics and Biosimilars Initiative Journal - Year 2014, Vol 3, Issue 2
Abstract
‘Non-binding recommendations’ from regulatory bodies are in place for evaluation and production of generic liposomal doxorubicin injection. However, how these nano-sized generics (‘nanosimilars’) should be characterized and evaluated, and particularly when the ‘reference listed product’ is no longer in production are among the major issues. We discuss these issues with respect to complexity of liposomal structure and vesicular population heterogeneity, and the challenges facing ‘nanosimilars’.
Authors and Affiliations
S Moein Moghimi, Z Shadi Farhangrazi
Keywords
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- EP ID EP354320
- DOI 10.5639/gabij.2014.0302.017
- Views 87
- Downloads 0
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