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.
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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).
The other six (Accretropin, Extavia, Filgrastim ratiopharm, NovoLog mix, PEGintron/ribetol combo, and Xyntha) are effectively
reformulated, biosimilar or "me too" versions of previously approved products (see sidebar: Biosimilar Products).
Product indications too are somewhat diverse and none aim to treat cancer. Also notable amongst the 2008 crop is the paucity
of antibody-based products. No full-length antibody came to the market last year, although one antigen-binding antibody fragment
(Cimzia) did gain approval.
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
In financial terms too, the majority of products approved, are expected to generate modest as opposed to blockbuster-level
revenues. Nplate, Xyntha, and Recthrom sales are each projected to reach the $300–500 million mark.5 Arcalyst, aimed at treating CAPS (Table 1) has designated orphan status. With an estimated total US population base of only
300–500 patients, the market potential has been estimated at $10–35 million, despite the drug's premium price (approximately
€250,000 per patient annually).6
Table 1. Biopharmaceuticals (defined as recombinant proteins, monoclonal antibody, and nucleic acid-based products) approved
in the US or EU in 2008
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.