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Lawmakers introduce biogenerics bill
Wednesday March 11, 2:17 pm ET
Bipartisan House group introduces bill to create pathway for approval of biotech-drug copies

NEW YORK (AP) -- A bipartisan group in Congress wants to give the Food and Drug Administration power to approve copies of costly biotech drugs.
Rep. Henry Waxman, a Democrat and chairman of the Energy and Commerce Committee, and Republican Nathan Deal introduced legislation to create a pathway for the approval of copies of biotechnology-based medical treatments. Biotech drugs are made in living cells.

There is no regulatory process for approving such copies in the U.S. That leaves the drugs' makers insulated from the generic competition the traditional drug industry faces. President Obama called recently for the creation of a regulatory pathway.