According to theWorld Health Organization, the incidence of malignant neoplasms and endocrine, blood, and immune disorders\nwill increase in the upcoming decades along with the demand of affordable treatments. In response to this need, the development of\nbiosimilar drugs is increasingworldwide.The approval of biosimilars relies on the compliance with international guidelines, starting\nwith the demonstration of similarity in their physicochemical and functional properties against the reference product. Subsequent\nclinical studies are performed to demonstrate similar pharmacological behavior and to diminish the uncertainty related to their\nsafety and efficacy.Herein we present a comparability exercise between a biosimilar trastuzumab and its reference product, by using\na hierarchical strategy with an orthogonal approach, to assess the physicochemical and biological attributes with potential impact\non its pharmacokinetics, pharmacodynamics, and immunogenicity. Our results showed that the high degree of similarity in the\nphysicochemical attributes of the biosimilar trastuzumab with respect to the reference product resulted in comparable biological\nactivity, demonstrating that a controlled process is able to provide consistently the expected product.These results also constitute\nthe basis for the design of subsequent delimited pharmacological studies, as they diminish the uncertainty of exhibiting different\nprofiles.
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