title: Fractal geometry as a new approach for proving nanosimilarity: a reflection note.
abstract: Nanosimilars are considered as new medicinal outcomes combining the generic drugs and the nanocarrier as an innovative excipient, in order to evaluate them as final products. They belong to the grey area - concerning the evaluation process - between generic drugs and biosimilar medicinal products. Generic drugs are well documented and a huge number of them are in market, replacing effectively the off-patent drugs. The scientific approach for releasing them to the market is based on bioequivalence studies, which are well documented and accepted by the regulatory agencies. On the other hand, the structural complexity of biological/biotechnology-derived products demands a new approach for the approval process taking into consideration that bioequivalence studies are not considered as sufficient as in generic drugs, and new clinical trials are needed to support their approval process of the product to the market. In proportion, due to technological complexity of nanomedicines, the approaches for proving the statistical identity or the similarity for generic and biosimilar products, respectively, with those of prototypes, are not considered as effective for nanosimilar products. The aim of this note is to propose a complementary approach which can provide realistic evidences concerning the nanosimilarity, based on fractal analysis. This approach is well fit with the structural complexity of nanomedicines and smooths the difficulties for proving the similarity between off-patent and nanosimilar products. Fractal analysis could be considered as the approach that completely characterizes the physicochemical/morphological characteristics of nanosimilar products and could be proposed as a start point for a deep discussion on nanosimilarity.
authors: Department of Pharmaceutical Technology, Faculty of Pharmacy, Panepistimioupolis Zografou 15771, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: demetzos@pharm.uoa.gr.
authors: Costas
authors: C
authors: Demetzos
authors: Department of Pharmaceutical Technology, Faculty of Pharmacy, Panepistimioupolis Zografou 15771, National and Kapodistrian University of Athens, Athens, Greece.
authors: Natassa
authors: N
authors: Pippa
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000737:chemistry / Q000592:standards*; D017277:Drug Approval; D016568:Drugs, Generic / Q000737:chemistry / Q000592:standards*; D017709:Fractals; D006801:Humans; D050997:Nanomedicine; D049329:Nanostructures / Q000737:chemistry* / Q000592:standards*
chemical_list: D059451:Biosimilar Pharmaceuticals; D016568:Drugs, Generic
keywords: Biosimilars; Biotechnology-derived products; European Medicines Agency; Fractal analysis; Guidelines; Nanosimilars