EC approves Sandoz' Omnitrope
Sandoz, the generic drugs unit of Swiss drug major Novartis, has been granted marketing authorization for its recombinant human growth hormone Omnitrope, a generic version of Pfizer's Genotropin.
The EC's clearance followed a positive opinion issued by the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) in January (Marketletter February 6). Omnitrope will be the first biotechnology product to be launched that has been approved under the EC's biosimilar pathway.
Sandoz expects to begin marketing the agent soon, following negotiations with government health authorities regarding pricing and other regulatory requirements. Germany and Austria will be the first markets in Europe; the product is currently on the market in Australia, where it was launched in November 2005.
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