Biologic Data Exclusivity – Part II

Last week I wrote about the biologic data exclusivity debate and suggested that the industry focus on a metric to determine the amount of time a new drug should be able to maintain exclusivity.

The next day an op-ed piece showed up in the Washington Times that exemplified why such a metric is needed.  In the article the author, who is the CEO of a company that produces a biosimilar, argues that a 12-year data exclusivity period is “unnecessarily lengthy” based on return on investment.  He says,

“Innovator companies argue for long exclusivity periods for their products, saying that the cost of developing biologics is so expensive that they need more time without competition to gain back their expenses and save jobs for their workers. But a recent study by AARP’s Public Policy Institute reveals that manufacturers of many top-selling biologic drugs have recouped average research and development costs several times over in the past six years, often within a single year.”

To my point, if the argument for data exclusivity is based on return on investment, a metric should be developed to drive the appropriate term of protection for each drug.  To arbitrarily set a data exclusivity period to cover all biologics with no basis of objective measurement is merely dartboard politics.




About Mike

Mike has been an executive in the biotechnology industry for the past 20 years. Mike is a graduate of University of California, Santa Barbara, earning Bachelors degrees in Business Economics and Geography. Mike also earned his MBA in Finance from California State University, Fresno. Mike is married to the mother of his 3 children and currently lives outside of Boulder, CO. In his spare time Mike enjoys hiking, fishing, skiing, reading and coaching basketball.
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