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Iron sucrose: assessing the similarity between the originator drug and its intended copies
Author(s) -
Di Francesco Tiziana,
Philipp Erik,
Borchard Gerrit
Publication year - 2017
Publication title -
annals of the new york academy of sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.712
H-Index - 248
eISSN - 1749-6632
pISSN - 0077-8923
DOI - 10.1111/nyas.13517
Subject(s) - authorization , iron sucrose , sucrose , iron deficiency anemia , drug , chemistry , anemia , computational biology , pharmacology , iron deficiency , medicine , food science , computer science , intravenous iron , biology , computer security
Iron sucrose (IS) is a complex nanocolloidal intravenous suspension used in the treatment of iron‐deficiency anemia. Follow‐on IS products (iron sucrose similars (ISSs)) have obtained marketing authorization by the generic pathway, implying that identical copies of IS may be manufactured. However, recent prospective and retrospective clinical studies showed discrepancies in clinical outcomes, which might be related to differences in physicochemical properties. The aim of this work is to measure and compare the physicochemical properties of IS and three ISSs available in the market using innovative analytical procedures. The comprehensive elucidation of size, size distribution, morphology, and stability of these complex drugs revealed very significant differences between the products. This study serves to provide the basis to define critical quality attributes that may be linked to differences in clinical outcome and thus may contribute to an adequate regulatory approach for IS and its follow‐on products.