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data exclusivity

With the issue of data exclusivity for novel biologics re-emerging in the news, I’d like to present two arguments that will be published in the upcoming issue of the Journal of Commercial Biotechnology:

Why data exclusivity is the new patent protection
Peter J Pitts, Center for medicine in the public interest

Follow-on biologic drug competition – No need for new marketing exclusivities
Michael S Wroblewski(a) and Elizabeth A Jex(b)
a) Office of Policy Planning, Federal Trade Commission
b) FTC Office of Policy Planning

Biotechnology Industry Organization CEO Jim Greenwood appeared on CNBC’s SquawkBox defending the case for data exclusivity protection for novel biologic drugs. The video appears below. Interestingly, he used the Aspirin vs. Epogen comparison from my book, Building Biotechnology, when he was explaining the difference between small molecule and biologic drugs to members of congress.