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Monoclonal antibody successes in the clinic

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Most monoclonal antibodies in clinical trials are owned by small biotech companies. But with blockbuster-sized revenues and approval rates higher than those for small-molecule drugs, that all may be set to change.

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Figure 1: Number of therapeutic mAbs entering clinical study per year (1980–2004).
Figure 2: Clinical phase transition percentages for therapeutic mAbs, according to FDA data.
Figure 3: Therapeutic categories for mAbs in clinical study.

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Acknowledgements

The authors gratefully acknowledge the assistance of the companies that provided survey data. We also thank H. Pujar for reviewing the manuscript and for providing helpful comments and suggestions.

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Authors and Affiliations

  1. Tufts University Center for the Study of Drug Development (CSDD), 192 South Street, Suite 550, Boston, 02111, Massachusetts, USA

    Janice M Reichert, Clark J Rosensweig, Laura B Faden & Matthew C Dewitz

Author notes

  1. Clark J. Rosensweig and Matthew C. Dewitz were summer interns at CSDD.

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    1. Janice M Reichert
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    2. Clark J Rosensweig
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    3. Laura B Faden
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    4. Matthew C Dewitz
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    Reichert, J., Rosensweig, C., Faden, L. et al. Monoclonal antibody successes in the clinic. Nat Biotechnol 23, 1073–1078 (2005). https://doi.org/10.1038/nbt0905-1073

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