Biogenerics 2007: How far have we come?

The recent approval of a follow-on version of Pfizer's Genotropin (recombinant human growth hormone) signalled the beginning of the end of an era in which biopharmaceuticals enjoyed immunity from competition even after expiration of their patent protection. This paper describes many of the key scientific challenges facing the nascent ‘biogenerics’ industry and the evolving regulatory framework that will shape its competition with innovator companies. We describe key differences between the biogeneric and traditional generic drug business models and the M&A activity that been undertaken in pursuit of the expertise and resources needed to be competitive in this commercial space. We conclude with a discussion of the commercial opportunity presented by recent and upcoming European patent expirations and the challenges presented by competition from second-generation innovator products.