Omnitrope, which is produced by Novartis' generics division Sandoz, is a copycat version of Pfizer's biotechnology product Genotropin. The approval marks the first time a biogeneric drug has been approved under a new approvals process.
Sandoz brought legal action against the FDA last year in order to force the agency to make a decision on the drug, a judge ruled in April of this year in support of the Sandoz motion. Omnitrope was eventually approved in the US using a pathway of the Hatch-Waxman act.
“The FDA's approval is a breakthrough in our goal of making high-quality and cost-effective follow-on biotechnology medicines like Omnitrope available for health care providers and patients worldwide,” said Dr Andreas Rummelt, CEO of Sandoz. “The approval of Omnitrope is a major step forward in bringing needed clarity to the approval process for follow-on biotechnology medicines in the US.”
The FDA's decision follows the approval of Omnitrope on April 19 by the European Commission. Omnitrope is now on the market in Germany, with launches planned for additional countries in Europe later this year. Omnitrope is also available in Australia, where it was launched in November 2005.