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Data exclusivity for biologics

Nature Reviews Drug Discovery volume 10, pages 15–16 (2011)Cite this article

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An Erratum to this article was published on 01 June 2011

Data exclusivity is the length of time before a biosimilar can receive approval from the US Food and Drug Administration by relying at least in part on the safety and efficacy data for the pioneer biologic. Data exclusivity is one factor contributing to market exclusivity — the period of time during which a therapy is the only marketed version of that molecule — but not the only determinant. The results of patent litigation, the time spent in development and regulatory review, commercial decisions by competitors, and other factors all contribute to the market exclusivity period. The appropriate length of the data exclusivity period was widely debated before the abbreviated pathway for biosimilars was enacted; indeed, the US Congress considered bills with periods ranging from 5 years to 14 years. An earlier article intended to help inform this debate developed a financial model to evaluate how long a market exclusivity period would be required until a typical pioneer biologic earned a positive investment return2. In this model (see Supplementary information S1 (box) for details), a representative portfolio of pioneer biologics would be expected to 'break-even' (or to recover the average costs of development, manufacturing and promotion, and the cost of capital) in 12.9–16.2 years. Here, we present an analysis incorporating two refinements that have been made to this model that directly address important concerns that were raised during the debate leading up to the enactment of the recent US legislation.

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Figure 1: Cumulative net present value (NPV) of cash flows for a representative biologic with various scenarios for market exclusivity.
Figure 2: Influence of data exclusivity and patent protection on break-even points for a representative biologic portfolio.

References

  1. Title VII of the Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111–48, Improving Access to Innovative Medical Therapies—Subtitle (2010).

  2. Grabowski, H. Follow-on biologics: data exclusivity and the balance between innovation and competition. Nature Rev. Drug Discov. 7, 479–488 (2008).

    Article  CAS  Google Scholar 

  3. Federal Trade Commission (FTC). Emerging Health Care Issues: Follow-on Biologic Drug Competition. Federal Trade Commission Report | June 2009. FTC website [online], (2009).

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Author information

Authors and Affiliations

  1. Henry Grabowski is at Duke University, Durham, North Carolina 27708, USA.,

    Henry Grabowski

  2. Genia Long and Richard Mortimer are at Analysis Group Inc., Boston, Massachusetts 02199, USA.,

    Genia Long & Richard Mortimer

Authors
  1. Henry Grabowski
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  2. Genia Long
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  3. Richard Mortimer
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Corresponding author

Correspondence to Henry Grabowski.

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Competing interests

The authors declare no competing financial interests.

Supplementary information

Supplementary information Box S1

Details of modelling and analysis (PDF 356 kb)

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Grabowski, H., Long, G. & Mortimer, R. Data exclusivity for biologics. Nat Rev Drug Discov 10, 15–16 (2011). https://doi.org/10.1038/nrd3277

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