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. 2012 Spring;9(1):24-7.

Innovation and Competition: Will Biosimilars Succeed?: The creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. But so are efficacy and patient safety

Erwin A Blackstone, Joseph P Fuhr Jr

Innovation and Competition: Will Biosimilars Succeed?: The creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. But so are efficacy and patient safety

Erwin A Blackstone et al. Biotechnol Healthc. 2012 Spring.

Abstract

Biosimilars are here, but there's no clear pathway yet for their approval. Difficult realities about their effect on drug prices, innovation, and competition need to be faced.

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Figures

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Erwin A. Blackstone, PhD, [top] is professor of economics at Temple University, in Philadelphia.
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Joseph P. Fuhr Jr., PhD, is professor of economics at Widener University, in Chester, Pa.
FIGURE
FIGURE
Global spending for biologics and biosimilars (U.S. dollars) CAGR=compound annual growth rate. Source: Adapted from IMS MIDAS Biosimilars, IMS Health, 2010, 2011
See this image and copyright information in PMC

References

    1. Alazraki M. How to approve ‘biosimilar’ drugs? The FDA has to figure that out. Daily Finance. http://www.daily-finance.com/2010/11/03/biosimilar-drugs-fda-approval-pr.... Accessed Feb. 15, 2012.
    1. Blackstone EA, Fuhr JP. Biosimilars and innovation: an analysis of the possibility of increased competition in biopharmaceuticals. Future Med Chem. 2010;2:1641–1649. - PubMed
    1. Brookings Institution Biosimilars in the United States: implementation challenges and lessons learned from the European Union [transcript] Dec. 2010. http://www.brookings.edu/events/2010/1201_biosimilars.aspx. Accessed Feb. 15, 2012.
    1. Carlson B. Satisfaction guaranteed or your money back. Biotechnol Healthcare. 2009;6(4):14–22. - PMC - PubMed
    1. Carroll J. FDA outlines steep hurdles, early fees for first-gen biosimilars. FierceBiotech. http://www.fiercebiotech.com/print/node/108932. May 10, 2011. Accessed Feb. 15, 2012.

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