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Cheap, Generic 'Biologics' on the Way?

Congress Considers Allowing Companies to Make Low-Cost Copies of Drugs Like Insulin

Complex as a 'Skyscraper'

A bill introduced last month would give the FDA the power for fast-track approval of generic biologics on a case-by-case basis, as long as companies can show they are essentially equivalent to the brand-name parent.

"The science supports an abbreviated pathway for [generic] biologics," said Sen. Hillary Rodham Clinton, D-N.Y., one of several sponsors of the bill. "We are finally at a place where we are debating how, not if."

Meanwhile, several key Republicans said the bill does not do enough to ensure the safety and effectiveness of highly complex biologic drugs.

Wyoming Sen. Mike Enzi, the senior Republican on the Senate Health, Education, Labor, and Pensions Committee, said if traditional drugs are as complex as a house, biologics were more akin to "a skyscraper."

"One girder out of place could cause the entire structure to fall," he said.


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