EU approves generic biologic

The European Commission has given Sandoz, the generic drug arm of Novartis, the green light to bring the first generic biologic onto the market. Omnitrope, a recombinant human growth hormone, is a generic version of Pfizer's Genotropin and Serono's Saizen, which had sales in 2005 of $808 million and $207 million, respectively. Sandoz says the drug initially will be launched in Germany and Austria after it sorts out pricing and other issues with European Union health authorities. Sandoz has been chasing approval for the drug in both the EU and the U.S. since 2003. However, the U.S. lacks a clear regulatory pathway for approving generic biologics, and FDA has dragged its heels in allowing such products onto the market (see page 28).