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Generic biologic drugs unlikely to offer significant savings

share," Grabowski said.

The research team, which also included David Ridley, a professor in Duke's Fuqua School of Business, will publish the paper, "Entry and Competition in Generic Biologicals," in the journal Managerial and Decision Economics. The research was funded by Genentech, which produces biologics.

In order to predict prices of generic biologics, the researchers combined a theoretical model of generic biologics with historical data from the generic pharmaceutical market.

Generic pharmaceutical products are widely accepted as a less-expensive alternative to brand-name drugs. Companies are able to sell generics for less because they do not have to repeat the studies required to win initial approval from the FDA. If manufactured according to the standards set forth for the initial approval of the treatment, the generic product is assumed to have the same safety and efficacy profile as the branded version.

Because of their unique characteristics, however, generic biologics probably face higher clinical, manufacturing and marketing costs to enter the market, according to the researchers.

Another barrier for generic biologics is that they probably will not be approved by the FDA as therapeutically equivalent to the reference brand, the researchers said. Generic pharmaceuticals can be substituted for the brand name by a pharmacist under state substitution laws aimed at cutting prescription costs. But without equivalency, a physician would specifically have to prescribe the generic biologic.

In recent congressional testimony, Grabowski called for a 10-year period in which makers of generic biologics could not use data developed by makers of original products in marketing applications for generic biologics. Otherwise, generics potentially could enter the market before originators have earned a positive return on their sizeable investments in research and development, he said.

U.S. Rep. Henry Wax
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Contact: Laura Brinn
laura.brinn@duke.edu
919-660-2903
Duke University
1-May-2007


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