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).

Article  CAS  PubMed  PubMed Central  Google Scholar 

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).

Article  CAS  PubMed  Google Scholar 

Schellekens, H. & Jiskoot, W. J. Immunotoxicol. 3, 123–130 (2006).

Article  CAS  PubMed  Google Scholar 

Hunt, D. et al. N. Engl. J. Med. 370, 1270–1271 (2014).

Article  PubMed  PubMed Central  Google Scholar 

Soulières, D. et al. BMC Cancer 16, 19 (2016).

Article  PubMed  PubMed Central  Google Scholar 

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).

Article  CAS  Google Scholar 

Elliott, S. et al. Exp. Hematol. 32, 1146–1155 (2004).

Article  CAS  PubMed  Google Scholar 

Zeerleder, S. et al. Pharmaceuticals (Basel) 14, 54 (2021).

Article  CAS  PubMed  Google Scholar 

LeBowitz, J. H. et al. Proc. Natl. Acad. Sci. USA 101, 3083–3088 (2004).

Article  CAS  PubMed  PubMed Central  Google Scholar 

Reggiori, F. et al. Glycoconj. J. 38, 625–647 (2021).

Article  CAS  PubMed  PubMed Central  Google Scholar 

Lee, K. et al. Glycobiology 13, 305–313 (2003).

Article  PubMed  Google Scholar 

Lee, J. H. et al. BioDrugs 33, 411–422 (2019).

Article  PubMed  PubMed Central  Google Scholar 

Kim, S. et al. MAbs 9, 704–714 (2017).

Article  CAS  PubMed  PubMed Central  Google Scholar 

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).

Article  CAS  PubMed  Google Scholar 

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).

Article  PubMed  PubMed Central  Google Scholar 

Duivelshof, B. L. et al. Anal. Chim. Acta 1089, 1–18 (2019).

Article  CAS  PubMed  Google Scholar