Pre-market development times for biologic versus small-molecule drugs

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Fig. 1: Cumulative distribution of time from first patent filing (Patent Priority Date) to FDA approval for biologics versus small molecules.


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The authors thank the US Patent and Trademark Office for providing access to patent term restoration data. A.S.K.’s work is supported by Arnold Ventures, the Harvard–MIT Center for Regulatory Science, and the Engelberg Foundation.

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Correspondence to Reed F. Beall.

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The authors declare no competing interests.

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Editor’s note: This article has been peer-reviewed.

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Supplementary Information

Supplementary Table 1 and Supplementary Figure 1

Supplementary Data

Small- vs. large-molecule development times

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Beall, R.F., Hwang, T.J. & Kesselheim, A.S. Pre-market development times for biologic versus small-molecule drugs. Nat Biotechnol 37, 708–711 (2019).

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