Tuesday, October 16, 2007
Biopharmaceuticals: Approval Trends in 2006
The year 2006 witnessed the approval of 13 biopharmaceuticals in the United States or European Union (Table 1) including four hormones, three antibody-based products, three therapeutic enzymes, one recombinant vaccine, an anticlotting agent, and a nucleic acid–based product. Major target indications included hereditary genetic conditions (four products), growth deficiency (two products), and neovascular macular degeneration (two products).
Only 10 of the 13 products were genuinely new to the market. Naglazyme, Tysabri, and Macugen, although approved in one region last year, had gained approval before 2006 in some other world region.
In terms of expression systems used, five of the approved biopharmaceuticals are produced in mammalian cell lines, four in Escherichia coli, and two in Saccharomyces cerevisiae, again confirming the prominence of these three expression systems in the biopharmaceutical sector. One product (Macugen) is produced by solid-phase organic synthesis. Another (Atryn) is particularly noteworthy because it is the first biopharmaceutical produced in a transgenic animal to gain regulatory approval.
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