So many obstacles that one wag speculates the road to biosimilars - or follow-on biologics or biogenerics - may not be paved until 2010, or even 2012. What’s standing in the way? All sorts of things, writes Ramsey Baghdadi in The RPM Report.

For one, Ted Kennedy may not be around to push legislation while he seeks cancer treatment. The Medicare compromise bill, Baghdadi speculates, is the most likely piece of health legislation to make it through Congress this year, but biosimilars aren’t in either Democratic or Republic versions. The election year is slowing everything down. Biotechs and generics are still far apart on such key issues as data exclusivity. And satisfying two key congressmen - Henry Waxman and John Dingell - is a must.

So Baghdadi suggests circling PDUFA V, or the next version of the Prescription Drug User Fee Act, on your calendars.

“We expect a compromise to be hammered out over the next year or two and attached to the user fee bill when it comes up for reauthorization in 2012,” he writes, noting that the first negotiations over PDUFA V will start in 2010. “It will be much easier to attach a ready-made piece of legislation to the next user fee iteration then than to try and rush something through Congress that doesn’t meet everyone’s threshold for satisfaction.

Meanwhile, the House Energy and Commerce Committee, which Dingell chairs, has just released responses from 35 companies and organizations to an April 3 request for input on creating a biosimilar pathway. Here are the replies.