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PATENTS

The characteristics of patents impacting availability of biosimilars

Nature Biotechnology volume 40, pages 22–25 (2022)Cite this article

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The large number of biologic drug patents in the United States has contributed to delays in biosimilar availability.

Biologic drugs such as monoclonal antibodies and gene therapies have become mainstays in the treatment of many diseases, but also focal points in the debate over pharmaceutical pricing. Biologics accounted for 48% of net manufacturer revenue and 43% of total medicine spending in the United States in 2019, and have been forecasted for continued rapid growth1. Derived from living systems, they are more difficult to produce than small-molecule drugs. Biologics are also more expensive. Many of the most widely used biologics have annual net prices of more than US$30,000 per year, including the monoclonal antibodies intended to treat inflammatory diseases: Humira (adalimumab, US$39,751), Cimiza (certolizumab, US$48,193) and Enbrel (etanercept, US$43,910)2. These high prices have placed increasing strain on the healthcare system as biologics have increased as a proportion of new drug approvals. Between 1996 and 2000, 14% of US Food and Drug Administration (FDA)-approved new drugs were biologics; by contrast, between 2016 and 2020, 26% were biologics3.

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Fig. 1: Claim types among litigated biologic patents.
Fig. 2: Priority, application and grant timing of litigated biologic patents.

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Acknowledgements

This work was supported by Arnold Ventures.

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Authors and Affiliations

  1. Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA

    Victor L. Van de Wiele, Reed F. Beall, Aaron S. Kesselheim & Ameet Sarpatwari

  2. Department of Community Health Sciences and O’Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada

    Reed F. Beall

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  1. Victor L. Van de Wiele
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  2. Reed F. Beall
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  4. Ameet Sarpatwari
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Correspondence to Ameet Sarpatwari.

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Van de Wiele, V.L., Beall, R.F., Kesselheim, A.S. et al. The characteristics of patents impacting availability of biosimilars. Nat Biotechnol 40, 22–25 (2022). https://doi.org/10.1038/s41587-021-01170-5

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