Sandoz receives European Commission marketing authorization for Omnitrope

By Lisa Kerner

Erie, Pa., April 18 - Sandoz, a division of the Novartis group, said the European Commission has granted marketing authorization for Omnitrope, the company's recombinant human growth hormone.

"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," Sandoz chief executive officer Andreas Rummelt said in a company news release.

"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 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 in January.

Sandoz said Omnitrope will be the first approved biosimilar to be marketed that has been approved under the biosimilar pathway of the European Commission.

The company plans to market Omnitrope first in Germany and Austria. It is on the market in Australia, where it was launched in November 2005.

Sandoz is seeking approval from the Food and Drug Administration and had filed a lawsuit against the agency seeking a ruling on its Omnitrope application. A recent judgment requires the FDA to issue a decision on Sandoz's application for Omnitrope, which was filed in July 2003.

Sandoz is a generic pharmaceutical company based in Holzkirchen, Germany.

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