Sandoz/Novartis' Omnitrope is first "generic biological" to be approved by US FDA

Sandoz, the generic medicines unit of Swiss drug major Novartis, says it has achieved a "precedent" after the US Food and Drug Administration cleared its recombinant human growth hormone Omnitrope, the first follow-on version of a biotechnology drug to be approved in the USA, the world's largest pharmaceutical market.

Sandoz' treatment for growth disorders in children and adults was passed using the so-called 505(b)(2) pathway of the Hatch-Waxman Act and the FDA has stressed that the agent is similar, but not equivalent, to Pfizer's Genotropin.

In full-year 2005, sales of the Genotropin rose 10% worldwide, earning the world drug giant $808.0 million, $280.0 million of which came from the USA. The FDA's decision will allow Sandoz to compete with seven other companies in the US market for this indication, which is worth $600.0 million annually.