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Amgen v. Sanofi: Critical Impact on the Value of Innovative Science in Antibody Discovery

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Fig. 1

Notes

  1. Consideration of non-CDR regions of antibodies to be nearly consistent for an antibody isotype and subclass refers to nonengineered antibodies. It should be noted that antibody engineering strategies have been introduced to confer desired properties for some mAb, including modulation of FcRn binding, modulation of Fcgamma-receptor binding, modulation of glycosylation sites, etc.

References

  1. Bosch F, Rosich L. The contributions of Paul Ehrlich to pharmacology: a tribute on the occasion of the centenary of his Nobel Prize. Pharmacology. 2008;82(3):171–9. https://doi.org/10.1159/000149583.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  2. Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature. 1975;256(5517):495–7.

    Article  CAS  PubMed  Google Scholar 

  3. Glassman PM, Balthasar JP. Physiologically-based pharmacokinetic modeling to predict the clinical pharmacokinetics of monoclonal antibodies. J Pharmacokinet Pharmacodyn. 2016. https://doi.org/10.1007/s10928-016-9482-0.

    Article  PubMed  Google Scholar 

  4. Glassman PM, Balthasar JP. Physiologically-based modeling to predict the clinical behavior of monoclonal antibodies directed against lymphocyte antigens. MAbs. 2017;9(2):297–306. https://doi.org/10.1080/19420862.2016.1261775.

    Article  CAS  PubMed  Google Scholar 

  5. Liu H, Gaza-Bulseco G, Faldu D, Chumsae C, Sun J. Heterogeneity of monoclonal antibodies. J Pharm Sci. 2008;97(7):2426–47. https://doi.org/10.1002/jps.21180.

    Article  CAS  PubMed  Google Scholar 

  6. Ishii-Watabe A, Kuwabara T. Biosimilarity assessment of biosimilar therapeutic monoclonal antibodies. Drug Metab Pharmacokinet. 2019;34(1):64–70. https://doi.org/10.1016/j.dmpk.2018.11.004.

    Article  CAS  PubMed  Google Scholar 

  7. Tu SS, Nagar S, Van de Wiele VL. Broad patent claims come before the supreme court in Amgen v Sanofi. JAMA. 2023. https://doi.org/10.1001/jama.2023.5638.

    Article  PubMed  Google Scholar 

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Correspondence to Joseph P. Balthasar.

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Conflict of Interest

JPB has served as a consultant for several pharmaceutical companies, including Amgen, Sanofi, Eli Lilly, Merck, Janssen, Pfizer, and Takeda. JPB serves as the Director of the Center for Protein Therapeutics, which is sponsored by AbbVie, Amgen, AstraZeneca, CSL-Behring, Eli Lilly, Genentech, Glaxosmithkline, Janssen, Merck, Roche, Sanofi, and Seagen. JPB receives research support from the Center for Protein Therapeutics and from the National Institutes of Health (CA246785, CA256928, CA261343, CA275967). JPB is a co-founder of Abceutics, Inc., a biotechnology company involved in the development of antibody fragment drugs, and JPB reports patents relating to the discovery and use of monoclonal antibody drugs.

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Balthasar, J.P. Amgen v. Sanofi: Critical Impact on the Value of Innovative Science in Antibody Discovery. AAPS J 25, 51 (2023). https://doi.org/10.1208/s12248-023-00816-3

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