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Precision and robustness of 2D-NMR for structure assessment of filgrastim biosimilars

Nature Biotechnology volume 34, pages 139–141 (2016)Cite this article

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To the Editor:

With the advent of biosimilar versions of brand biologics, regulatory authorities in all major jurisdictions throughout the world have developed guidance documents to facilitate their approval1,2,3,4. The common theme in the new documents is the stipulation that sponsors must demonstrate biosimilarity between their proposed product and an approved reference product using state-of-the-art analytical technologies. In the US guidance documents, a “totality of evidence” approach is described that can be used to establish the degree of similarity and guide regulatory decision-making3,4.

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Figure 1: Spectral and statistical comparisons of NMR data.

References

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Authors and Affiliations

  1. Division of Pharmaceutical Analysis, US Food and Drug Administration, Center for Drug Evaluation and Research, St. Louis, Missouri, USA

    Houman Ghasriani, Lucinda F Buhse & David A Keire

  2. Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate, Health Canada, Ottawa, Ontario, Canada

    Derek J Hodgson & Yves Aubin

  3. Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology, Rockville, Maryland, USA

    Robert G Brinson & John P Marino

  4. Medical Products Agency of Sweden, Uppsala, Sweden

    Ian McEwen

  5. US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Biotechnology Products, Silver Spring, Maryland, USA

    Steven Kozlowski

Authors
  1. Houman Ghasriani
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  2. Derek J Hodgson
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  7. John P Marino
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  8. Yves Aubin
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  9. David A Keire
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Corresponding authors

Correspondence to John P Marino, Yves Aubin or David A Keire.

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Ghasriani, H., Hodgson, D., Brinson, R. et al. Precision and robustness of 2D-NMR for structure assessment of filgrastim biosimilars. Nat Biotechnol 34, 139–141 (2016). https://doi.org/10.1038/nbt.3474

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