Biotechnology Group Praises Biologic Drugs Bill

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; [e-mail].

(Alicia Mundy contributed to this report.)