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Focus (Forum & Focus)

Apr. 9, 2009

A Prescription for Change?

Congress is considering multiple bills directed at streamlining the pathway for generic biologic drugs, write Knobbe Martens attorneys Thomas Krzeminski and Marko Zoretic.

FOCUS COLUMN

By Thomas Krzeminski and Marko Zoretic

The regulatory approval system for generic drugs, established in 1984 by the Hatch-Waxman Act, has been extremely successful in lowering the high cost of prescription drugs as a result of generic competition. But in the biotech drug industry, also known as biologics, generic competition is nonexistent. Presently there is no regulatory pathway for generic versions of biologics, even after all pat...

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