FDAnews Drug Daily Bulletin


April 20, 2006

The European Commission (EC) has granted marketing authorization for German-based Sandoz's recombinant human growth hormone Omnitrope. It will be the first biosimilar to be marketed that has been approved under the EC's biosimilar pathway.

The EC decision to grant marketing authorization follows a positive opinion issued in January by the European Medicines Agency's Committee on Medicinal Products for Human Use.

"While citizens in the EU and Australia now have access to affordable generic biopharmaceuticals, Americans are being denied access because of political reasons," Generic Pharmaceutical Association (GPhA) President Kathleen Jaeger said. "It's clear that science supports the approval of safe and effective generic biopharmaceuticals under an abbreviated pathway."

Sandoz is already one step closer to entering the U.S. market after a federal district court recently ordered the FDA to make a decision about Omnitrope. Sandoz sued the FDA in 2005, accusing the agency of unlawfully delaying a decision on the firm's application to market generic human growth hormone.

"The court rules that the 180-day statutory provision imposes a mandatory obligation on the FDA and that the FDA failed to so act," Judge Ricardo Urbina of the U.S. District Court for the District of Columbia wrote recently. Urbina called the agency's nearly 1,000-day review of Omnitrope "unreasonable" in light of the 180-day review deadline mandated by statute.

Sandoz expects to begin marketing the product soon, following negotiations with government health authorities regarding pricing and other regulatory requirements, the company noted. The drug will first be made available in Germany and Austria. It is currently on the market in Australia, where it was launched in November 2005.