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Formatting example © COMPOSITE AUTHORS, 20__ UDC 615.07:615.275.4 Biosimilars of the recombinant granulocyte colony stimulating factor. Quality assessment A. A. Ivanov, S. S. Petrov, E. E. Nikolaeva, O. O. Sergeeva Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation, Moscow, Russia Submitted: __.__.20__ Accepted for publication: __.__.20__ The article describes general principles of evidence-based quality assessment research of a recombinant granulocyte colony stimulating factor preparation (G-CSF) under development, as well as confirmation of its similarity to the innovator (authorised original product). Since the quality of biotech products is determined by the manufacturing process, when developing a biosimilar, one should focus on the manufacturing process details, including the selection of the expression system, the composition of excipients, and the methods of recombinant protein isolation and purification. The recombinant protein should be characterised in more detail, than the quality parameters of the original preparation, included in the specification of the substance or the preparation. Comparative studies include characterisation of the active substance and assessment of the finished product quality. It is a general practice to use Neypogen ® as a reference preparation for the development of a biosimilar G-CSF (filgrastim). A number of analytical techniques require using the WHO reference material – International Standard for GCSF NIBSC (code 09/136). Comparative studies include assessments of the composition; physical and chemical properties; primary structure and protein conformation; purity, qualitative and quantitative content of related substances and impurities associated with the process; and biological activity. The active substance (recombinant protein) in a biosimilar product must be similar to the active substance in the original product (innovator). If there are any significant differences found in terms of quality parameters of the newly developed product and the innovator, that can affect efficacy and (or) safety, the product is not considered to be biosimilar to the innovator. Quality assessment studies are the first stage of drug evaluation. The results determine the need for further preclinical and (or) clinical trials, as well as their scope and type. The provisions stated in the present article are based on the experience of quality assessment of filgrastim preparations approved by the CHMP in the EU as “biosimilars”, “biosimilar medicinal products”. Key words: recombinant granulocyte colony stimulating factor; filgrastim; biosimilars; original products (innovators); active substance; substance; comparative studies; confirmation of similarity; quality assessment; stability evaluation. Bibliographic description: Ivanov AA, Petrov SS, Nikolaeva EE, Sergeeva OO. Biosimilars of the recombinant granulocyte colony stimulating factor. Quality assessment. BIOpreparations (Biopharmaceuticals) 20__; (*): ***. TEXT OF THE ARTICLE References 1. … 2. … 3. … Authors Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation, 8/2 Petrovsky boulevard, Moscow, 127051, Russian Federation. Ivanov AA. … Petrov SS. … Nikolaeva EE. … Sergeeva OO. … Contact e-mail: Ivanov AA.; [email protected]
