You think the drug shortage is a devil now Just wait around a few years ’Cause you ain’t seen nothin’ yet. When that biosimilar pathway begins to flash Those big green dollar signs, You’ll know, you’ll know, you’ll know, you just ain’t seen nothin’ yet. Those biosimilars will turn your heart away from the old drugs of yesterday. You’ll think you have it comin’, and you’ll want it that way. You’ll say big profits are good profits, so you’ll take what you can get. B-B-B-Baby, you ain’t seen n-n-n-nothin’ yet. Patients will go to the doctor, and he’ll tell them...

Regulatory certainty. It’s something industry needs and investors want to see. It’s also one of the drivers for job creation. But it’s something our government doesn’t seem to get. Take the president’s repeated call for shorter data exclusivity for biologics, beginning in 2012. Just last year, Congress made 12 years the law of the land. Changing it now is a) premature, b) unnecessary and c) absolutely pointless. As we’ve reported in BioWorld Today, the FDA is not ready to be deluged with biosimilar applications. And the biosimilar user fees that will pay for the path won’t even be in place...