Biopharmaceuticals: Approval Trends in 2008

The year 2008 was, like 2007, a somewhat disappointing year in terms of the number of new biopharmaceuticals approved. The year witnessed the approval of eight recombinant proteins or engineered antibody-based products in the US, and two such biopharmaceuticals in the European Union (EU, Table 1). These products included hormones, interferons, blood factors, and fusion proteins—two each—as well as one antibody-based product and a colony-stimulating factor.
Although 10 approvals does not appear an unduly low number, only four of those products contained genuinely new active ingredients (Arcalyst, Cimzia, Nplate, and Recothrom; Table 1). Arcalyst and Nplate are fusion proteins, Cimzia is an antibody Fab', and Recothrom is a recombinant thrombin (blood coagulation factor IIa).