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Monoclonal antibody successes in the clinic

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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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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Author notes

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


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    Reichert, J., Rosensweig, C., Faden, L. et al. Monoclonal antibody successes in the clinic. Nat Biotechnol 23, 1073–1078 (2005).

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