UPDATE 1-Lawmakers: Generic biologics unlikely in FDA bill

Thu Sep 6, 2007 2:54pm EDT
 
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(Recasts with second lawmaker; Adds comments from Hospira, brand-name lobbying group)

By Lisa Richwine and Kim Dixon

WASHINGTON, Sept 6 (Reuters) - Lawmakers are unlikely to add generic biologics legislation to a Food and Drug Administration bill expected to receive congressional approval this month, two key U.S. congressmen said on Thursday.

Generic drugmakers have been pushing legislation that would set a clear path for the FDA to approve cheaper copycat versions of biotechnology medicines.

The chances of adding the generic biologics measure to a broad FDA bill now moving through Congress are "extremely slim," Rep. Henry Waxman, a California Democrat, told a Generic Pharmaceutical Association conference.

The FDA legislation, which includes drug safety reforms and other measures, must pass by the end of September in order to maintain industry fees that help fund drug reviews.

Biotech medicines often cost tens of thousands of dollars per patient each year. They treat a range of diseases including cancer, multiple sclerosis and rheumatoid arthritis.

Unlike traditional chemical-based drugs, biologics are derived from living things. Brand-name manufacturers say biologics are much tougher to copy than chemical-based medicines, and small changes can make the drugs ineffective or potentially harmful.   Continued...

 

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