The European Commission has granted marketing authorization for Sandoz'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 Dr. Andreas Rummelt, CEO 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," he added.
The European Commission's decision to grant marketing authorization followed a positive opinion issued by the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) in January. Omnitrope will be the first Biosimilar to be marketed that has been approved under the biosimilar pathway of the European Commission. "Omnitrope is the first of several Biosimilar products that Sandoz is pursuing," Rummelt stated.