Sandoz will launch the recombinant human growth hormone follow-on Omnitrope (somatropin) in Germany and Austria in the coming days after gaining European Commission approval, the company announced April 18.

It is the first follow-on biologic approved under the EU's biosimilar pathway. In January, EMEA recommended that the EC grant Sandoz marketing authorization for Omnitrope (¹ Also see "Sandoz Omnitrope Gains First “Similar Biological” Positive Opinion In the EU" - Pink Sheet, 27 January, 2006.).

Sandoz must finalize pricing and reimbursement in other EU member states prior to launching, but says Omnitrope will likely be available in several other countries by the end of the year.

In 2003, before the pathway was established, EMEA backed the approval of Omnitrope, but the EC blocked marketing authorization.

Sandoz says it is currently pursuing six other follow-on biologics in the EU.

Omnitrope is a generic version of Pfizer's human growth deficiency therapy Genotropin , which lost patent protection in 2004.

EU approval of Omnitripe comes amid a flurry of activity. On April 10, a U.S. federal judge ruled that FDA must decide either to approve or deny Omnitrope (see ² Also see "FDA Not Following Up On Follow-On, Sandoz Says" - Pink Sheet, 18 April, 2006. ).

- Todd Leeuwenburgh

Omnitrope Gains Final EU Approval

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