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. 2024 Sep 30;38(6):755–767. doi: 10.1007/s40259-024-00671-4

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© The Author(s) 2024

Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

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Fig. 1 — The totality of evidence data package for the development and approval of biosimilar medicines compared to reference medicines. In vivo preclinical studies are not a requirement from the European Medicines Agency and US Food and Drug Administration for the approval of biosimilar medicines when extensive analytical and functional characterization has already demonstrated the proposed biosimilar and reference medicines to be highly similar [9, 22, 38]. PD pharmacodynamics, PK pharmacokinetics