Notes
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
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.
Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature. 1975;256(5517):495–7.
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.
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.
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.
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.
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.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
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.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
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
Received:
Accepted:
Published:
DOI: https://doi.org/10.1208/s12248-023-00816-3