REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot84910.21518/1561-5936-2021-2-8-24Original ArticleBiosimilars: reproduction of the clinical profile using modern biotechnologyNiyazovRavil R.-DranitsynaMargarita A.-VasilievAndrey N.-GavrishinaElena V.-Center of Scientific Advice14122021282417032022Copyright © 2021,2021A biosimilar is a biological medicinal product whose active substance is a version of an active substance of the previously authorised biological medicinal product. The approach taken to develop biosimilar products is fundamentally different from the one used for a new biological medicinal product because the main efforts are directed towards reproducing the original active substance to the greatest possible extent. The biosimilarity concept recognises that it is impossible to reproduce the original biopharmaceutical in full. Thus, it allows for certain differences if they do not cause a significant negative impact from the clinical point of view. To show biosimilarity, an extensive analytical testing program should be implemented where all detected differences are then evaluated in the functional assays. The subsequent non-clinical or clinical tests are needed to demonstrate that the biosimilar delivers the same clinical effect as the reference biological product, but not to prove, yet again, the safety and efficacy of the biological active substance per se by reproducing the development program of the reference biologic.biosimilarbiotechnologyvariabilitycomparabilityбиоаналогбиосимилярбиотехнологиявариабельностьсопоставимость1.U.S. Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs – Humulin R. Official website of the U.S. Food and Drug Administration. 28 October 1982. Available at: https://accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018780.2.Davy A.M., Kildegaard H.F., Andersen M.R. Cell Factory Engineering. 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