Budget has mandate for biogeneric approvals

Buried in the modest 5.7 percent budget hike for the FDA is a provision that the government will seek authority to begin approving generic versions of biologics. Despite heavy support for the measure, lawmakers failed to get a bill in 2007 that would mandate a regulatory pathway for follow-on biologics, or biogenerics. The 1984 generic drug law excludes most biotech products, a feature that has enhanced the sector for investors and aroused the fiercely protective nature of a host of industry lobbyists. This time around, though, biogeneric legislation could get the boost it needs if the White House actively pursues it.

- read the report [1] in the Wall Street Journal

ALSO: Opponents of a patent reform bill that changes the way damages are assessed in patent reform cases got a boost from the Bush Administration. Report [2]

PLUS: Any big fix at the FDA may have to wait for a new president. The White House's proposed budget includes a funding increase of just 5.7 percent for the agency, a hike that's significantly absorbed by inflation. Report [3]

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Waiting game continues for biogenerics. Report [4]
Dr. Reddy's make risky biogenerics move. Report [5]
Lawmakers propose pathway for approving biosimilars. Report [6]