Under the Hatch-Waxman Act, drug manufacturers can market generic versions of a drug provided a sponsor can show bioequivalence. But because of a quirk in the history of drug regulation, products regulated as biologicals can not follow the conventional path to generic approval. The biotechnology industry opposes licensure on the basis of bioequivalence, arguing that "the process is the product." Does this sound familiar to anyone? It might be a plausible position: different manufacturing processes can alter protein folding or post-translational modifications, which in turn can affect immunogenicity and pharmacokinetics. But it directly contradicts the biotechnology industry's position that GM foods should be regulated as products, not processes. (photo credit: Steelepop 2006)
Thursday, March 20, 2008
A Fruity Defense?
...Another reason why drugs like Cerezyme are so expensive is because it is very difficult for generic drug companies to license follow-on (that is, generic) drugs under existing drug regulations. In the March 17 issue of New England Journal of Medicine, two Boston-based researchers review the legal and regulatory environment for generic protein-drugs.
Posted by Jonathan Kimmelman at 12:52 PM