Germany's Sandoz has announced that the European Commission (EC) has granted marketing authorization for the company's recombinant human growth hormone Omnitrope.
"We are pleased that the European Commission has taken the final step in approving Omnitrope for marketing in Europe, and we will quickly bring this product to market for the patients and physicians who need it," said Andreas Rummelt, CEO of Sandoz. "As more biotechnology-based products come off patent, biosimilars will play an increasingly important role by providing lower-cost, safe and effective versions of patent-expired biological medicines."
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. Omnitrope will be the first biosimilar to be marketed that has been approved under the biosimilar pathway of the European Commission.
Sandoz expects to begin marketing the product soon, the company noted, following negotiations with government health authorities regarding pricing and other regulatory requirements. 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.