Biotechnology Group Praises Biologic Drugs Bill
March 17 2009 - 5:54PM
Dow Jones News
Biotechnology companies praised a bill introduced in Congress
Tuesday that would preserve the period under which they can
exclusively sell brand-name biologic drugs without competition from
rivals offering cheaper generic versions.
The bill, introduced by Reps. Anna G. Eshoo, D.-Calif., Joe
Barton, R.-Texas, and Jay Inslee, D.-Wash., gives brand-name
biologic makers 12 years of exclusivity before generic versions can
hit the market.
The Biotechnology Industry Organization, the industry's advocate
group, said the bill strikes the right balance between innovation
and balance. The industry group had denounced a bill earlier this
month introduced by Rep. Henry Waxman, D.-Calif., that would give
brand-name biologics five years of exclusivity, saying it would
undercut innovation.
The Eshoo-Barton-Inslee bill "provides patients with the right
balance between innovation and competition," said Jim Greenwood,
president of the biotechnology industry group, in a statement.
Biologics are complex and expensive medicines derived from
proteins manufactured in living cells. Traditional drugs are made
by mixing chemicals.
Eshoo introduced a similar bill in 2007 to no avail, and Waxman
had previously introduced his bill twice. Though it's ultimately
unclear which bill will have more legs, Waxman is now chairman of
the powerful House Energy and Commerce Committee, and President
Barack Obama highlighted the need for cheap biologics in his budget
proposal last month.
Such brand-name biologic makers as Genentech Inc. (DNA) have
worked to fend off generic versions of their products and defeat
Waxman's efforts.
Currently, makers of generic biologics must go through the same
expensive and time-consuming clinical trials and other requirements
that new drugs face.
Waxman's bill leaves the details of the approval process to the
Food and Drug Administration and doesn't say whether the generic
makers would have to carry out clinical trials. By contrast, the
Eshoo-Barton-Inslee bill requires companies to conduct analytical
studies to show their drugs are similar to marketed treatments.
Europe currently allows the sale of follow-on biologics without
more clinical trial data.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com.
(Alicia Mundy contributed to this report.)