This is a preview of subscription content, access via your institution
Access options
Access Nature and 54 other Nature Portfolio journals
Get Nature+, our best-value online-access subscription
$29.99 / 30 days
cancel any time
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
References
Schneider, C. K. & Kalinke, U. Nat. Biotechnol. 26, 985–990 (2008).
Schneider, C. K. et al. Nat. Biotechnol. 30, 1179–1185 (2012).
Schiestl, M. et al. Biologicals 42, 128–132 (2014).
Lamanna, W. C. et al. Expert Opin. Biol. Ther. 18, 369–379 (2018).
Kirchhoff, C. F. et al. Biotechnol. Bioeng. 114, 2696–2705 (2017).
Walsh, G. Nat. Biotechnol. 36, 1136–1145 (2018).
Udpa, N. & Million, R. P. Nat. Rev. Drug Discov. 15, 13–14 (2016).
Vezér, B., Buzás, Z., Sebeszta, M. & Zrubka, Z. Curr. Med. Res. Opin. 32, 829–834 (2016).
Schneider, C. K. Ann. Rheum. Dis. 72, 315–318 (2013).
Acha, V. & Mestre-Ferrandiz, J. Technol. Anal. Strateg. Manage. 29, 263–275 (2017).
World Health Organization Expert Committee on Biological Standardization. Fortieth report, annex 4: Guidelines for the preparation, characterization and establishment of international and other standards and reference reagents for biological substances. In WHO technical report series 800, 181–213. https://digicollections.net/medicinedocs/documents/s16116e/s16116e.pdf (1990).
World Health Organization. Providing international biological reference preparations. https://www.who.int/biologicals/reference_preparations/en/ (2021).
UK National Institute for Biological Standards and Control. WHO international standards. https://nibsc.org/products/brm_product_catalogue/who_standards.aspx (2021).
Prior, S. et al. MAbs 10, 129–142 (2018).
Metcalfe, C. et al. MAbs 11, 13–25 (2019).
World Health Organization Expert Committee on Biological Standardization, Wadhwa, M. et al. Report on a collaborative study for proposed 1st international standard for adalimumab. https://www.who.int/publications/m/item/WHO-BS-2019.2365 (2019).
World Health Organization Expert Committee on Biological Standardization, Prior, S. et al. Report on a collaborative study for proposed 1st international standard for the biological activities of trastuzumab. https://www.who.int/publications/m/item/who-bs-2020.2401 (2020).
World Health Organization Expert Committee on Biological Standardization, Jia, H. et al. WHO international collaborative study for the proposed 1st international standard for bevacizumab. https://www.who.int/publications/m/item/WHOBS2020.2391 (2020).
World Health Organization Expert Committee on Biological Standardization. Proposed first international standards (or reference reagents) for monoclonal antibodies to the ErB/HER receptor family. In sixty-seventh report, WHO technical report series 1004, 54–55. http://apps.who.int/iris/bitstream/10665/255657/1/9789241210133-eng.pdf (2017).
World Health Organization Expert Committee on Biological Standardization. Proposed first WHO international standards for vascular endothelial growth factor antagonists. In sixty-seventh report, WHO technical report series 1004, 52–53. http://apps.who.int/iris/bitstream/10665/255657/1/9789241210133-eng.pdf (2017).
Thorpe, R. & Wadhwa, M. Biologicals 39, 262–265 (2011).
European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en.pdf (2006).
World Health Organization Expert Committee on Biological Standardization. Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs). In sixty-seventh report, WHO technical report series 1004, 93–127. http://apps.who.int/iris/bitstream/10665/255657/1/9789241210133-eng.pdf (2017).
US Food and Drug Administration. Development of therapeutic protein biosimilars: comparative analytical assessment and other quality-related considerations. Guidance for industry: draft guidance. https://www.fda.gov/media/125484/download (2019).
Bielsky, M. C. et al. Drug Discov. Today 25, 1910–1918 (2020).
Schiestl, M. et al. Nat. Biotechnol. 29, 310–312 (2011).
Kim, S. et al. MAbs 9, 704–714 (2017).
Lee, J. H. et al. BioDrugs 33, 411–422 (2019).
Generics and Biosimilars Initiative. Biosimilars in emerging markets. Generics and Biosimilars Initiative Journal http://gabi-journal.net/news/biosimilars-in-emerging-markets (2015).
Kang, H. N., Thorpe, R. & Knezevic, I., Survey participants from 19 countries. Biologicals 65, 1–9 (2020).
Acknowledgements
The authors wish to thank the Scientific Advice, Human Medicines Research & Support Division from the EMA for providing the information on the Scientific Advice procedures used in Supplementary Fig. 1. This paper is based on independent research commissioned and funded by the NIHR Policy Research Programme (NIBSC Regulatory Science Research Unit). The views expressed in the publication are those of the author(s) and not necessarily those of the NHS, the NIHR, the Department of Health, ‘arms-length’ bodies or other government departments.
The National Institute for Biological Standards and Control (NIBSC) is a center of the Medicines and Healthcare Products Regulatory Agency, an Agency of the UK Government’s Department of Health and Social Care. It fulfills its public health role through the standardization and control of biologicals used in medicine. NIBSC’s strategy includes anticipating emerging quality and safety issues associated with existing and future biological medicines, and facilitation of the development of novel biological medicines and diagnostics. In some instances, it is appropriate for NIBSC to charge commercial and other organizations for its products and services, in line with guidance issued from Her Majesty’s Treasury (‘Fees & Charges Guide’ and ‘Selling into Wider Markets’). NIBSC endeavors to make the same products and services equally available to commercial organizations, without prejudice.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Competing interests
The authors declare no competing interests.
Supplementary information
Supplementary Information
Supplementary Fig. 1 and Supplementary Tables 1 and 2
Rights and permissions
About this article
Cite this article
Prior, S., Metcalfe, C., Hufton, S.E. et al. Maintaining ‘standards’ for biosimilar monoclonal antibodies. Nat Biotechnol 39, 276–280 (2021). https://doi.org/10.1038/s41587-021-00848-0
Published:
Issue Date:
DOI: https://doi.org/10.1038/s41587-021-00848-0
This article is cited by
-
Quantification of SARS-CoV-2 monoclonal IgG mass fraction by isotope dilution mass spectrometry
Analytical and Bioanalytical Chemistry (2024)