ARTICLE | Regulation
Opening an EPO Front in Europe
April 15, 2002 7:00 AM UTC
Countdown to Biogenerics
While hGH and urokinase are likely to be the flashpoints for the U.S. debate on biogenerics, in Europe the first struggle could be over the blockbuster erythropoietin market. At least six companies hope to launch biogeneric EPO in Europe in 2004 or 2005, and several told BioCentury that they have received indications from European regulators that it may be possible to obtain approval based on an abbreviated set of clinical trials. ...