Senate and House conferees are not expected to add establishment of a regulatory pathway for follow-on biologics to the comprehensive Food and Drug Administration bill set to receive final Congressional approval later this month, according to two key House members.

Rep. Henry Waxman (D-CA) said prospects of incorporating a so-called generic biologics provision in the reauthorization of FDA safety legislation are "extremely slim." Rep. Frank Pallone (D-NJ) also said he thought it unlikely House and Senate negotiators could agree in time on a biologics approach.

A Senate committee passed the Biologics Price Competition and Innovation Act earlier this summer, establishing a way for the FDA to approve biosimilars, and Sen. Edward M. Kennedy (D-MA) had expressed hope this bill could be wrapped into the FDA safety bill.

But Pallone, who chairs the House Energy and Commerce health subcommittee, said he had concerns about the Senate approach.

The House has taken no action thus far this year on legislation that would establish a pathway for FDA approval of biosimilars, but Pallone said "We're not just going to take the Senate bill."

Pallone said he anticipated additional hearings will be held on follow-on biologics and added: "We will try to come up with a consensus and try to work it out with the Senate this year."

Waxman said he was "hopeful" Congress would be able to pass a follow-on biologics bill before the end of 2008.

The two lawmakers spoke at a Generic Pharmaceutical Association conference.