liposomes. Non-equivalence of NBCD follow-on versions, authorised by the classical generic paradigm, which is not valid for these highly complex synthetic nanoparticle drugs, has triggered these considerations.3
Therefore a similar
instead of a sameness approach is necessary,12
and a defined and accepted
nomenclature is lacking but is mandatory for harmonised regulations. Whereas for nanomedicines a defined similar approach is almost lacking, support and experience from the biosimilar approach could be used to progress, although these nanosimilars are synthetic and therefore not biological. l
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