The year 2009 bucked the trend of low biopharmaceutical approval numbers witnessed over the last several years. A total of
20 recombinant proteins and monoclonal antibody-based products were approved in the US or the EU over the year. These included
seven antibody-based products, four erythropoietins or colony stimulating factors, two each of blood related products, hormones,
and fusion proteins, as well as an interferon, a recombinant vaccine, and a bone morphogenetic protein-based product (Table
1). The increased approval numbers is welcome news indeed, although it remains to be seen if it represents a sustained upward
trend or just a blip in annual approval rates. There are signs, however, that 2010 also will be a productive year, with 10
biopharmaceuticals having gained approval in the EU or the US by the end of June.
Cumulatively, 2009 approvals bring the total number of biopharmaceuticals approved to 200, and the overall 2009 global market
value for biopharmaceuticals was estimated at $99 billion.1
Absolute approval numbers, while providing an important indicator of the sector, do not provide a complete picture. Equally
significant indicators include the number of approvals genuinely new to the market and their potential market value.
Fourteen of the 20 products approved in 2009 were genuinely new to the market. The other six, although newly approved in one
region last year, had gained approval before 2009 in the other region (Table 1). Eight of the 14 new products contained genuinely
novel active ingredients (Arzerra, Ilaris, Kalbitor, Removab, Roactemra, Simponi, Stelara, and Victoza) while six were biosimilars,
reformulated, or "me too" products (Filgrastim hexal, Zarzio, Opgenra, Fertavid, Biopoin, and Eporatio).
Table 1. Biopharmaceuticals approved in the US or the European Union in 2009
Autoimmune or autoinflammatory conditions represented the principle target indication (seven products), while other target
indications included cancer treatment or prevention (three products), anemia, neutropenia, and hereditary conditions (two
products each), as well as infertility, diabetes, thrombocytopenia, and promotion of spinal fusion (single products in each
The predicted market potential for these new approvals—where data is available—is mixed. Reformulated or biosimilar products
generally enter a competitive market place where they must fight for market share. For example, the European biosimilar market
was estimated at $60 million in 2008, while the US biosimilar market is projected to reach a modest $30 million by 2013.2 However, as more biopharmaceuticals come off patent and more biosimilars are commercialized, market share will grow, and
some analysts predict that several individual biosimilar products will reach blockbuster status (>$1 billion in annual sales)
before the end of the decade.
The market value of several of the genuinely new biopharmaceutical entities approved will likely be modest. For example, Kalbitor
is indicated for the treatment of a rare genetic disorder (hereditary angioedema) and analysts predict sales to peak at approximately
$150 million annually. On the other hand, sales of Simponi (an anti-TNF antibody indicated for rheumatoid and psoriatic arthritis)
and of Victoza (a glucagon-like peptide receptor agonist indicated for type 2 diabetes) are each predicted to reach blockbuster
status within the next few years.
In terms of expression systems used, 11 of the 20 approved biopharmaceuticals are produced using mammalian cell lines, five
in E. coli, two in yeast (one each in S. cerevisiae and P. pastoris), and one each in an insect cell–based expression system and a transgenic system. These figures once again reflect the ongoing
dominance of mammalian-based expression systems in biopharmaceutical manufacturing.