Maintaining ‘standards’ for biosimilar monoclonal antibodies thumbnail

Maintaining ‘standards’ for biosimilar monoclonal antibodies

References

  1. 1.

    Schneider, C. K. & Kalinke, U. Nat. Biotechnol. 26, 985–990 (2008).

    CAS 
    Article 

    Google Scholar
     

  2. 2.

    Schneider, C. K. et al. Nat. Biotechnol. 30, 1179–1185 (2012).

    CAS 
    Article 

    Google Scholar
     

  3. 3.

    Schiestl, M. et al. Biologicals 42, 128–132 (2014).

    Article 

    Google Scholar
     

  4. 4.

    Lamanna, W. C. et al. Expert Opin. Biol. Ther. 18, 369–379 (2018).

    CAS 
    Article 

    Google Scholar
     

  5. 5.

    Kirchhoff, C. F. et al. Biotechnol. Bioeng. 114, 2696–2705 (2017).

    CAS 
    Article 

    Google Scholar
     

  6. 6.

    Walsh, G. Nat. Biotechnol. 36, 1136–1145 (2018).

    CAS 
    Article 

    Google Scholar
     

  7. 7.

    Udpa, N. & Million, R. P. Nat. Rev. Drug Discov. 15, 13–14 (2016).

    CAS 
    Article 

    Google Scholar
     

  8. 8.

    Vezér, B., Buzás, Z., Sebeszta, M. & Zrubka, Z. Curr. Med. Res. Opin. 32, 829–834 (2016).

    Article 

    Google Scholar
     

  9. 9.

    Schneider, C. K. Ann. Rheum. Dis. 72, 315–318 (2013).

    CAS 
    Article 

    Google Scholar
     

  10. 10.

    Acha, V. & Mestre-Ferrandiz, J. Technol. Anal. Strateg. Manage. 29, 263–275 (2017).

    Article 

    Google Scholar
     

  11. 11.

    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).

  12. 12.

    World Health Organization. Providing international biological reference preparations. https://www.who.int/biologicals/reference_preparations/en/ (2021).

  13. 13.

    UK National Institute for Biological Standards and Control. WHO international standards. https://nibsc.org/products/brm_product_catalogue/who_standards.aspx (2021).

  14. 14.

    Prior, S. et al. MAbs 10, 129–142 (2018).

    CAS 
    Article 

    Google Scholar
     

  15. 15.

    Metcalfe, C. et al. MAbs 11, 13–25 (2019).

    CAS 
    Article 

    Google Scholar
     

  16. 16.

    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).

  17. 17.

    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).

  18. 18.

    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).

  19. 19.

    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).

  20. 20.

    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).

  21. 21.

    Thorpe, R. & Wadhwa, M. Biologicals 39, 262–265 (2011).

    Article 

    Google Scholar
     

  22. 22.

    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).

  23. 23.

    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).

  24. 24.

    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).

  25. 25.

    Bielsky, M. C. et al. Drug Discov. Today 25, 1910–1918 (2020).

    CAS 
    Article 

    Google Scholar
     

  26. 26.

    Schiestl, M. et al. Nat. Biotechnol. 29, 310–312 (2011).

    CAS 
    Article 

    Google Scholar
     

  27. 27.

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

    CAS 
    Article 

    Google Scholar
     

  28. 28.

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

    Article 

    Google Scholar
     

  29. 29.

    Generics and Biosimilars Initiative. Biosimilars in emerging markets. Generics and Biosimilars Initiative Journal http://gabi-journal.net/news/biosimilars-in-emerging-markets (2015).

  30. 30.

    Kang, H. N., Thorpe, R. & Knezevic, I., Survey participants from 19 countries. Biologicals 65, 1–9 (2020).

    CAS 
    Article 

    Google Scholar
     

Download references

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

Affiliations

  1. National Institute for Biological Standards and Control (NIBSC), South Mimms, United Kingdom

    Sandra Prior, Clive Metcalfe, Simon E. Hufton, Meenu Wadhwa, Christian K. Schneider & Chris Burns

  2. Twincore Centre, Hannover Medical School, Hannover, Germany

    Christian K. Schneider

Corresponding author

Correspondence to
Sandra Prior.

Ethics declarations

Competing interests

The authors declare no competing interests.

Supplementary information

About this article

Verify currency and authenticity via CrossMark

Read More

Leave a Reply

Your email address will not be published. Required fields are marked *