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Biogenerics Firms: Where Part of Bigger May be Better

Executive Summary

The biogenerics industry is experiencing a painful adolescence. After taking off on the back of the biotech boom during the late 90s, it has since come down with a thud as costs and timelines rise beyond most firms' forecasts. Unlike the rest of the biotech sector, biogenerics firms can't yet point to a successful precedent, and regulatory and clinical risks remain considerable. So while the entrepreneurship and flexibility associated with traditional biotech can favor small, standalone firms, the opposite is true in biogenerics. Most of the (likely few) winners in this game will be those quietly developing biosimilar products within divisions of traditional generics players.

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FDA Hesitates on Biogenerics

A long-awaited Food and Drug Administration (FDA) workshop held in mid-September, highlighted just how far the agency is from establishing a regulatory path for generic copies of biologics. Although it yielded few surprises, the meeting provided a concentrated public forum for interested parties to present in-depth views of all sides of the issue--an unusual event in itself

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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