Any lingering hopes that legislation establishing a regulatory pathway for FDA approval of follow-on biologics would be enacted this year died as Congress this week passed and sent to the White House a sweeping FDA safety bill which included no provision for so-called generic biologic drugs.

Some Congressional Democrats, including the influential Sen. Edward M. Kennedy, had dangled out hope that Senate and House conferees would ultimately include a so-called generic biologics provision in their reauthorization of FDA safety legislation.

But the bill, which was past this week first by the House and then the Senate, included no such provision.

Most Congressional observers had considered it highly unlikely that House and Senate negotiators could agree on a biologics approach in time to include it in the safety bill, a compromise reached after months of negotiations. In the end these observers were proved correct.

While a Senate committee passed the Biologics Price Competition and Innovation Act earlier this summer, the House -- which was known to have concerns about the Senate approach -- has thus far taken no action on legislation that would establish a pathway for FDA approval of biosimilars.

Key House Democrats have expressed hope, however, that Congress will be able to pass a follow-on biologics bill before the end of 2008.