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 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

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

Suggested Articles

Across its 15-year history, Omega Funds has a hand in a clutch of high-profile biotechs such as Editas Medicine and Juno Therapeutics.

After Novartis’ near $10 billion buyout of The Medicines Company, many thought cardiovascular therapies were hot again.

The data position Leo to file for approval of the Dupixent rival in atopic dermatitis next year.