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Omnitrope Hiccup: How Not To File For Biogeneric Approval in Europe

Executive Summary

Sandoz's Omnitrop was expected to become the first marketed biogeneric in Europe, following a positive CPMP recommendation last June. But in March 2004 it emerged that the European Commission, in an unusual move, had blocked the drug's approval late last year. While certainly a setback for Sandoz, and hardly comforting to the rest of the sector, the events appear to result from a misunderstanding over the legal basis of the application, rather than from any deeper reluctance among European lawmakers to approve biosimilar products.

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