About half the prescriptions filled in the U.S. last year were for generic drugs. As the nation's health care costs soar ever skyward, the competition from low-priced generics adds essential ballast. But will the makers of generics be able to offer cut-price knockoffs of therapies that are the fruit of biotechnology? The Food and Drug Administration and its European counterpart are pondering the question now, and a great deal of money hinges on their decisions.
The patents on the first lucrative products of biotechnology are at last approaching their expiration dates. If competing firms are permitted to manufacture them, "biogeneric" versions of the off-patent medicines could command $5 billion next year, estimates the Strategic Research Institute, a consultancy in New York City. Regulators face a tough scientific question, however: How should they judge whether a biogeneric is equivalent to the brand-name therapy for which it substitutes?
This article was originally published with the title Can Cells Be Generic?.