Generic Biologics

Henry Waxman, Chuck Schumer and Hillary Clinton will introduce a bill Wednesday that provides the Food and Drug Administration with a roadmap for approving generic biologics. The Biotechnology Industry Association claims that each cell line used to manufacture biologics is different and therefore needs to go through all the same clinical trials as the original drug to prove comparable efficacy. The FDA has so far gone along with that logic, and as a result, some of the original biologics, like Amgen's Epogen, are now well into their third decade of patent protection (the original patent on Epogen was issued in 1984; it should have gone generic in 2004 at the latest).

Amgen, which rakes in over $2 billion a year in government payments for Epogen, has one of the best-organized and well-funded lobbying operations in the drug industry, which, as readers of this blog know, is not exactly full of slouches in that department. BIO, meanwhile, is headed by former Congressman James Greenwood, who has many powerful friends on the Hill. However, the bill already has a couple of Republican co-sponsors and the political stars are finally aligned for Amgen to suffer its first political defeat -- ever. It should be an interesting fight. We can worry about a Bush veto later.