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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Biotech Drug Copies Could Be Held Up 13 Years Under Senate Plan

Catherine Larkin of Bloomberg.com reports that Biotechnology drugs made by Amgen Inc. and Biogen Idec Inc. couldn’t be copied and sold for lower prices for 13 1/2 years after they’re marketed, or twice the time urged by President Barack Obama, under a Senate proposal...Generic copies of these treatments are needed to help cut costs in the overhaul of the nation’s $2.5 trillion health- care system, according to Obama.

In an email to Catherine Larkin, Katie Huffard executive director of the Coalition for a Competitive Pharmaceutical Market, a Washington- based organization of employers, insurers and consumer groups that have lobbied for generic drugs, said “At a time when policy makers are looking to lower health costs so more Americans can afford care, Senator Kennedy and others want to go in the opposite direction by keeping monopoly pricing."

What do you think about this issue? Will biosimiliars eventually have to wait 13 years?

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