CBO: Biogenerics Would Save Federal Government $6.6 Billion Over Ten Years

WASHINGTON, June 25, 2008 /PRNewswire-USNewswire/ -- The Congressional Budget Office (CBO) today released a cost analysis finding that the creation of an abbreviated pathway for follow-on biologics -- or biogenerics -- would save the federal government $6.6 billion over ten years and lower total expenditures for biologics by $25 billion over the same time period.

"For a quarter century, generic versions of chemical drugs have saved consumers and payors billions of dollars. Now, CBO has confirmed that giving FDA additional authority to approve generic versions of biologics will save billions more," "Even greater savings would be available if Congress simply applied to biologics the Hatch-Waxman standards that are currently used to approve generics for chemical compounds. It would be helpful if some provisions in the bill -- such as 'evergreening' -- which unnecessarily delay the entry of biogenerics were reconsidered. CBO acknowledges that the 'evergreening' issue will present significant problems beyond the ten-year scoring window."

CBO estimates that:

Unlike conventional drugs, there is no clear regulatory process where biogenerics can be approved by the FDA. PCMA was joined by a number of influential consumer, employer, and insurer groups who endorsed the bipartisan legislation that seeks to create a clear regulatory pathway for biogenerics.

CONTACT: Charles Cote of PCMA, +1-202-207-3605

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Posted: June 2008


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