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.

BioPartners GMBH isn't the only company vying for opportunities when patents on biologicals such as erythropoeitin (EPO) begin to expire in Europe, beginning as early as 2004. But the company has moved away from simply trying to re-produce existing products more cheaply—so-called "biogenerics". Instead, it's developing patented new formulations of therapeutic proteins that theoretically will offer concrete advantages over existing products, in terms of safety, dosing and price.

BioPartners' president and CEO Brian O'Callaghan is, like a growing number of industry players, skeptical as to whether simple copies...

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