Opening the door to off-patent biologics

WASHINGTON - Congress is likely to consider proposals next year to create clear regulatory pathways for approvals of off-patent, or follow-on versions of recombinant drugs and biologics. The generic drug industry and some consumer advocates already are gearing up to press for a streamlined regulatory process that would allow well-characterized biologics to be approved with few or minimal clinical trials in a process resembling generic drug approvals.

Two of the three trade associations representing generic drug companies merged this year, forming the Generic Pharmaceutical Association, in part to consolidate their influence on Capitol Hill. One of the new association's goals is clearing a regulatory pathway for off-patent biologics. And while the generics industry has in the past lacked champions in Washington, the mood in Congress has swung in its favor this year as views about "innovator" pharmaceutical companies have darkened...