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).
In terms of expression systems used, the 2008 approvals also appeared to buck the general trend toward mammalian-based systems. Six of the 10 approved products are expressed in E. coli, one in S. cerevisiae, and three in Chinese hamster ovary (CHO) cell lines. However, the E. coli bias is less obvious in the context of genuinely novel active pharmaceutical ingredients approved, of which two are expressed in E. coli and two in CHO cells.
In most previous years too, some overlap in EU and US approvals was evident.1–4 Not so in 2008. Although approval numbers in the US were modest, they were even more disappointing in EU, with only two products coming on the market. Moreover, neither of the EU approvals (Extivia and Filgrastim Ratiopharm) were genuinely novel (see sidebar).
The only product with a likely potential of reaching blockbuster status is that of Cimzia.5 Although initially approved only for the treatment of Chron's disease, it was subsequently approved (May 2009) for the treatment of rheumatoid arthritis, greatly increasing its revenue scope.
Overall, therefore, 2008 was a modest year in terms of biopharmaceutical approvals. Analysts, however, are hopeful that this will represent a low point, with approvals likely to steadily increase once again in the coming years.5
Individual monographs for products are presented below. Monograph for Extavia, Novologmix 50:50, and PEGintron ribetol are not provided, given their particularly close similarity to well-established, previously approved products.