Biogeneric Epo approved by EU
Date: 3.9.2007
Novartis' **generic drug** arm Sandoz has scored a key victory in the drive for biosimilars. The EU has approved its biogeneric **epoetin** alfa for patients with renal anemia and those receiving **chemotherapy**.
The decision is likely to add pressure on lawmakers and the FDA to come up with a well defined regulatory pathway for biosimilars in the U.S. Biotech lobbyists have argued strenuously that biologics are too complex to warrant any kind of **generic drug** process similar to that allowed for **traditional drugs**. But as European regulators approve more and more of these applications, they will continue to demonstrate that not all biologics are created with equal complexity.
"For more information":[ http://www.forbes.com/markets/feeds/afx/2007/08/31/afx4071227.html]
