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Biopharmaceutical benchmarks 2014

Monoclonal antibodies continue their march on the markets, optimized so-called biobetter versions of existing biologics are also gaining ground, but the rate of biosimilar approvals has seen a dramatic slowdown in recent years.

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Figure 1: Approvals by region and by date.
Figure 2: mAbs approved within the indicated periods, expressed as a percentage of total biopharmaceutical product approvals within the same period.
Figure 3: Product approvals, cumulative (1982–2014) and for the current period (2010–July 2014) in the context of product class.
Figure 4
Figure 5: Expression systems used to manufacture biopharmaceutical products.

References

  1. Walsh, G. Biopharmaceutical benchmarks. Nat. Biotechnol. 24, 769–776 (2006).

    Article  CAS  Google Scholar 

  2. Walsh, G. Biopharmaceutical benchmarks 2010. Nat. Biotechnol. 28, 917–924 (2010).

    Article  CAS  Google Scholar 

  3. Blackstone, E. & Fuhr, J. The Economics of biosimilars. American Health and Drug Benefits (July 2, 2014).

    Google Scholar 

  4. Rickwoood, S. & Di Biase, S. Searching for Terra Firma in the Biosimilars and Non-Original Biologics Market (IMS Health, Parsippany, NJ, USA, 2013).

    Google Scholar 

  5. Hospira Reports on success of its biosimilar proteins in Europe and Australia, La Meire Biologics 6, 3–4 (2013).

  6. Dalgaard, K. et al. Biosimilars Seven Years On: Where are We and What's Next? (McKinsey and Company, New York, NY, USA, 2013).

    Google Scholar 

  7. Perez, H.L. et al. Antibody–drug conjugates: current status and future directions. Drug Discov. Today 19, 869–881 (2014).

    Article  CAS  Google Scholar 

  8. Goede, V. et al. Comparison of Obinutuzumab (GA101) Plus Chlorambucil (Clb) Versus Rituximab Plus Clb in Patients with Chronic Lymphocytic Leukemia (CLL) and Co-Existing Medical Conditions (Comorbidities): Final Stage 2 Results of the CLL11 Trial. Presented at the 55th ASH Annual Meeting and Exposition. New Orleans, LA. December 7-10, 2013. Abstract 6.

  9. Nielsen, L.S. et al. Single-batch production of recombinant human polyclonal antibodies. Mol. Biotechnol. 45, 257–266 (2010).

    Article  CAS  Google Scholar 

  10. Kling, J. Sanofi to propel inhaled insulin Afrezza to market. Nat. Biotechnol. 32, 851–852 (2014).

    Article  CAS  Google Scholar 

  11. Kwon, K.C. et al. Oral delivery of human biopharmaceuticals, autoantigens and vaccine antigens bioencapsulated in plant cells. Adv. Drug Deliv. Rev. 65, 782–799 (2013).

    Article  CAS  Google Scholar 

  12. Emerton, D.A. Profitability in the biosimilars market: can you translate scientific excellence into a healthy commercial return? Bioprocess Int. 11, 6–14 (2013).

    Google Scholar 

  13. Brennan, T.A. & Wilson, J.M. The special case of gene therapy pricing. Nat. Biotechnol. 32, 874–876 (2014).

    Article  CAS  Google Scholar 

  14. PhRMA. Medicines in Development: Biologics. 2013 report. http://www.phrma.org/sites/default/files/pdf/biologics2013.pdf (PhRMA, Washington, DC, 2013)

  15. Olinger, G.G. et al. Delay treatment of Ebola virus infection with plant-derived monoclonal antibodies provides protection in rhesus monkeys. Proc. Natl. Acad. Sci. USA 109, 18030–18035 (2012).

    Article  CAS  Google Scholar 

  16. Qui, X. et al. Reversion of advanced Ebola virus disease in nonhuman primates with ZMapp. Nature 10.1038/nature13777 (29 August 2014).

  17. Broz, A., Huang, N. & Unruh, G. Plant-based protein biomanufacturing. Genet. Eng. Biotechnol. News 33, 32–33 (2013).

    Article  Google Scholar 

  18. Beck, A. & Reichert, J.M. Approval of the first biosimilar antibodies in Europe. MAbs 5, 621–623 (2013).

    Article  Google Scholar 

Download references

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Correspondence to Gary Walsh.

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Supplementary information

Supplementary Table 1

New traditional-type biotech product* approvals 2010-2014. (PDF 161 kb)

Supplementary Table 2

Stem cell products in phase 3 clinical trials (PDF 50 kb)

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Walsh, G. Biopharmaceutical benchmarks 2014. Nat Biotechnol 32, 992–1000 (2014). https://doi.org/10.1038/nbt.3040

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