Wednesday, August 26, 2009

Biosimiliars 2009 Speaker Professor Grabowski's Economic Analysis of Data Exclusivity for Follow-on Biologic Drugs


Kevin E. Noonan of Patientdoc.org writes that, Professor Henry Grabowski has been cited often in the data exclusivity debate, on the economic justification for a twelve-year data exclusivity period for biologic drugs. Dr. Grabowski (at right), a Professor at The Fuqua School of Business at Duke University, has some credibility (in addition to his academic credentials) for having the only peer-reviewed analysis of the topic (his paper, "Follow-on biologics: data exclusivity and the balance between innovation and competition," was published online in Nature Reviews Drug Discovery on May 12, 2008). Opponents cite his support by the Pharmaceutical Research and Manufacturers of America (PhRMA) as raising issues of impartiality (albeit in the face of frankly partisan contrary opinions that have not faced peer review). Under the circumstances, it is important to the debate that everyone be familiar with the assumptions, analysis, and conclusions presented by Professor Grabowski.

Professor Grabowski's Economic Analysis of Data Exclusivity for Follow-on Biologic Drugs

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