Saturday, November 12, 2005

Biogenerics

What it is: Generic forms of the patented drug proteins sold by big biotech firms.

Why it's hot: Companies like Amgen and Genentech rely heavily on expensive but effective protein-based therapies for diseases ranging from chronic renal failure to diabetes. These patented therapies, also known as biodrugs, accounted for $18 billion in sales last year. Now many of the best-selling biodrugs are going off patent - which means that if others can copy them, they can sell them.

But cloning a protein, with its complex molecular structure, is far more difficult than copying an aspirin. And unless it's a perfect clone, under today's rules, regulators will not approve it. Biogenerics are a major focus for pharmaceutical companies in China and India, and they are also likely to be sold in the European Union soon. The FDA is considering rules for the United States, however, and the industry is split on how to handle the new drugs. Biogenerics have the potential to capture roughly 11 percent of the total biodrug market, which could send prices plummeting.
Note from Technophile: That would be bad news for the likes of Genentech, but potentially great news for millions of patients!

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