Article: Biogenerics on horizon.(Drug approvals)(Brief article)

Moves are afoot in the US to promote the approval of biogeneric drugs. In an effort to bring down the prices of biotechnology therapeutics, Henry Waxman, Charles Schumer, Hillary Rodham Clinton and other lawmakers have introduced the Access To Life-saving Medicines Act. The law will give the US Food and Drug Administration (FDA) legal authority to approve safe copies of biotech drugs.

Biotech drugs (or biologicals) are among the fastest-growing but most expensive class of pharmaceuticals. However, there is no clear regulatory pathway for cheaper generic versions to be approved once the patents have expired. 'We learned 22 years ago that generic drug competition ...

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