Proposed Biosimilars Legislation Makes Progress

Washington, DC (Feb 8)-A follow-on biologics approval pathway may be on the way. US Health and Human Services Secretary Mike Leavitt accepted Sen. Charles Schumer’s (D-NY) suggestion that the US Food and Drug Administration and Congress work together to formulate legislation for such a pathway.

President George W. Bush’s fiscal year 2009 budget-which proposed a 5.7% increase from FY 2008-included funding for a follow-on biologics approval pathway (see Pharmaceutical Technology’sbudget request story), which is to come from user fees. But Schumer says the pathway must also allow products to be approved as interchangeable and grant innovator products “a reasonable period of exclusivity” so that follow-on biologics, or biosimilars, can be brought to market quickly, according to the Feb. 8 Drug Industry Daily.

“It is an encouraging sign that the administration not only included this proposal in its budget, but is prepared to sit down with Congress to figure out how to make the approval process work for manufacturers and the American people,” added Schumer.

A biosimilars pathway has been on the radar for some time. In early 2007, Senators sponsoring the Biologics Price Competition and Innovation Act 2007 attempted to establish a follow-on biologics approval pathway. The pathway failed to get into the FDA Amendments Act, which passed in Sept. 2007 (see Pharmaceutical Technology’sFDAAA story). The House has also introduced similar bills, such as HR 1038.