Angličtina
This book will review progress towards attaining a global consensus regarding the introduction of follow-on versions of non biological complex drugs (NBCD). A non biological complex drug is a medicinal product, not being a biological medicine, where the active substance is not a homo-molecular structure but consists of different (closely related and often nano particulate) structures that cannot be isolated and fully quantitated, characterized and/or described by state-of-the-art physicochemical analytical means and where the clinical meaning of the differences is not known. The composition, quality and in vivo performance of NBCD are highly dependent on manufacturing processes of both the active ingredient as well as in most cases the formulation. The challenges posed by the development of follow-on versions of NBCD are illustrated in this book. It discusses how the same principles for the marketing authorization of copies of NBCD as for biosimilars could be used: the need for animal and/or clinical data and the need to show similarity in quality, safety and efficacy. The regulatory approach of NBCD will have to take into consideration the specific characteristics of the drugs, their formulation and manufacturing process and the resulting critical attributes to achieve their desired quality, safety and efficacy. As with the biosimilars, for the NBCD product, family-specific methods should be evaluated and applied where scientifically proven, including sophisticated quality methods, pharmacodynamic markers and animal models.
