This past spring the Novartis subsidiary, Sandoz, made a bid to sell a copycat version of human growth hormone in the European Union and was rejected, triggering a law-suit between Sandoz and the EU that is still ongoing. In October, however, Australia approved the same copycat drug, called Omnitrope, making it the world's first approval of a so-called biogeneric in a regulated market.
The approval could be the first of many. Nearly $10 billion worth of biopharmaceuticals are expected to come off patent during the next five years, and firms that produce generic drugs want to jump in to exploit the niche. The lure of less expensive medication is strong: The biogenerics market is expected to reach $16 billion by 2007. However, biotechnology companies stand to lose billions in sales and are arguing that it's impossible to create safe and effective generic versions of their drugs.
Legislators around the world ...
