WorldChanging: Another World Is Here: Generic Biomedicine

From WorldChanging:

"The American patent on Human Growth Hormone -- useful for fighting wasting diseases associated with AIDS -- expired in 2003. So why isn't there a far-less-expensive 'generic' version available in the US? Because HGH is a protein 'biologic' drug, and protein drugs are far more difficult to produce than 'small molecule' drugs, and the FDA says it can't be certain that the generic versions are identical to the originals.

So goes the story in the December Technology Review. Biotech companies have made substantial sums on life-saving complex protein drugs, and now the patents are starting to expire. With 'small molecule' drugs (the kind regularly advertised on television and in the hundreds of pieces of spam you got today), the process of duplicating the molecule in order to create a generic version is straightforward, as are the tools for confirming that the drugs are identical. But proteins are big, complicated molecules, with varying properties depending on how they fold. Biomedical proteins aren't just conjured up in test tubes, but are often produced by reengineered bacteria. Duplication is difficult. But help is on the way..."