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Biogenerics: Threat or Opportunity?

Executive Summary

The EMEA's recommended approval of Novartis' generic growth hormone Omnitrop may pave the way for further biogeneric approvals in Europe. But high entry costs and questionable demand mean straight copies of biologics may not prove the most threatening to branded players/the most valuable market. The real battle will likely be around improved biologics: longer-lasting, safer and more efficacious versions. This widens the playing field, but places branded players with the advantage-for now.

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Glycoform Ltd.

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

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.

BioPartners' Biogeneric Alternative

Uncertainties surrounding the ill-defined notion of biogenerics prompted Switzerland's BioPartners to focus instead on developing improved, patent-protected formulations of biologicals, supported by full Phase III trials. The firm's financial backing, small size, and freedom from the low-cost philosophy hampering traditional generics players have worked in its favor--most recently, helping it win rights to a new formulation of interferon beta.

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