After two decades of experience with biosimilars, physicochemical and in vitro biological comparison with their reference products appear sufficient to guarantee clinical safety and efficacy. Hence, the regulation of biosimilars has become redundant, and biopharmaceuticals should now be regulated through the generic pathway available for small molecules.
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References
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (consolidated version 26/07/2019) (EU, 2019).
Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal L 136, 30/04/2004 P. 0034-0057 (EU Monitor, 2024).
Guideline on similar biological medicinal products. CHMP/437/04, Rev. 1 (EMA, 23 October 2014).
Senior, M. Nat. Biotechnol. 41, 174–182 (2023).
EMA. ICH S6 (R1). Preclinical safety evaluation of biotechnology-derived pharmaceuticals—Scientific guideline. EMA/CHMP/ICH/731268/1998 (EMA, June 2011).
EMA. Humira —EPAR—product information (SmPC) (EMA, 11 October 2022).
EMA. Remicade—EPAR—product information (SmPC) (EMA, 12 December 2018).
EMA. Eprex—SmPC (EMA, 24 June 2021).
EMA. Avastin—EPAR—product information (SmPC) (EMA, 17 March 2023).
Casadevall, N. et al. N. Engl. J. Med. 346, 469–475 (2002).
Schellekens, H. & Jiskoot, W. J. Immunotoxicol. 3, 123–130 (2006).
Hunt, D. et al. N. Engl. J. Med. 370, 1270–1271 (2014).
Soulières, D. et al. BMC Cancer 16, 19 (2016).
FDA (CDER). BLA 125291/136: Lumizyme (2013); https://www.accessdata.fda.gov/drugsatfda_docs/bla/2014/125291orig1s136.pdf
Bielsky, M. C. et al. Drug Discov. Today 25, 1910–1918 (2020).
Elliott, S. et al. Exp. Hematol. 32, 1146–1155 (2004).
Zeerleder, S. et al. Pharmaceuticals (Basel) 14, 54 (2021).
LeBowitz, J. H. et al. Proc. Natl. Acad. Sci. USA 101, 3083–3088 (2004).
Reggiori, F. et al. Glycoconj. J. 38, 625–647 (2021).
Lee, K. et al. Glycobiology 13, 305–313 (2003).
Lee, J. H. et al. BioDrugs 33, 411–422 (2019).
Kim, S. et al. MAbs 9, 704–714 (2017).
EMEA. Ontruzant—EPAR—assessment report EMEA/H/C/004323/0000 (EMA, 26 January 2018).
Pivot, X. et al. Eur. J. Cancer 120, 1–9 (2019).
Pivot, X. et al. Ann. Oncol. 32, S428 (2021).
WHO. Guidelines on evaluation of biosimilars—Replacement of Annex 2 of WHO Technical Report Series, No. 977 (WHO, 22 April 2022).
Čaval, T., Zhu, J. & Heck, A. J. R. Anal. Chem. 91, 10401–10406 (2019).
Duivelshof, B. L. et al. Anal. Chim. Acta 1089, 1–18 (2019).
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Doevendans, E., van Meer, P. & Schellekens, H. The devolution of biosimilars regulations. Nat Biotechnol 43, 19–22 (2025). https://doi.org/10.1038/s41587-024-02497-5
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DOI: https://doi.org/10.1038/s41587-024-02497-5
