The folks at BIO are breathing a sigh of relief over Congressman Henry Waxman's comment that new legislation on biosimilars was unlikely to reach the House floor this week. He chalked the delay up to scheduling issues. Of course, with the Democrats in charge of the House and Senate, one wonders why a piece of legislation like this can't go ahead swiftly. It's more than apparent that lawmakers are willing to create a regulatory pathway for generic versions of biotech drugs. And they'll more than likely follow the FDA's position that each of these biogeneric--or biosimilar--applications should be reviewed on a case-by-case basis. Where regulators see complexity in a biologic, they will raise the bar on data. Where a therapy can be copied without raising serious safety issues, which is now done routinely, it will be approved without a terribly demanding set of trials.
All of that is clear enough. So why the delay? I suspect lawmakers are just finding it tough to get their act together. That's one good reason for the growing level of public frustration at lawmakers of every stripe. PDUFA legislationÂ will go ahead because it has to. The FDA needs the money to operate. Meanwhile, the demand for less expensive biologics will only grow. Does anyone in Washington know how this game is played? - John Carroll