Biologic Data Exclusivity – One Size Doesn’t Have to Fit All

The debate over biologic data exclusivity continues in earnest.  How long should a biologic drug be protected from competition once it is approved by the FDA?  The argument has consequences for generic follow-on versions of many expensive biologic drugs currently on the market.

The range of proposals have included a 5-year period intended to mirror the current period awarded small molecule drugs under the Hatch Waxman Act,  a 7-year exclusivity by the Obama Administration and as high as 12-14 years by several industry groups, including the Biotechnology Industry Organization.

Reaching a consensus has been difficult because of the objective for providing one-size-fits-all legislation.  What if we took a different approach and tied data exclusivity to the amount of time and money it takes to develop a biologic subject to a maximum number of years?  This approach would provide necessary protection while taking into account the investment made in drug development.  Why should a biologic that was approved based on Phase II data be afforded the same protection as one that needed randomized Phase III data?  The cost of development between the two is significant.

In drug development time equals money.  The more money needed to develop a drug is typically tied to the increased time for running expensive clinical trials.  In developing a metric that takes into consideration the time/money relationship we may come up with a solution that is fair for the developer and consumer.




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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