Sandoz Lawsuit Vs. European Commission Highlights Uncertainties Over Biogenerics

Law360, New York (April 8, 2004, 12:00 AM EDT) -- In a case likely to have broad implications, Swiss generic drug maker Sandoz has filed a lawsuit against the European Commission for denying approval of the world’s first generic biotech drug.

In a decision that took the market by surprise, the European Union’s executive body rejected Sandoz’ application of its Omnitrop generic human growth hormone, citing filing irregularities.

However, Sandoz says it believes it used an appropriate pathway to file the drug, and officials told the media they were engaged in an ongoing dialogue with the...
To view the full article, register now.