This article is part of PharmTech's supplement "API Synthesis and Formulation 2009."
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Biosimilars, also known as follow-on biologics, generic biologics, and biogenerics, remain somewhat controversial, but their
potential to yield cost savings is inspiring pro-biosimilar legislation in developed pharmaceutical markets such as Europe
and the United States. Key patents for several first-generation biologics are set to expire, or have already done so, in the
seven major markets (i.e., France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States). Although these
drugs represent the low-hanging fruit of the biologics world in terms of ease of development and commercialization, they are
unlikely to provide biopharmaceutical manufacturers with the monetary gains that complex biologics bring. First-generation
biosimilars will likely provide indirect benefits such as allowing the key biosimilars players to establish themselves within
the industry. Europe, Germany in particular, is emerging as the testing ground for biosimilars, but the US market will prove
to be the real prize for biosimilars manufacturers.
Biosimilars uptake set to grow
Figure 1: Prediction of biosimilar sales by product in seven major markets (i.e., France, Germany, Italy, Japan, Spain, the
United Kingdom, and the United States) during 2008–2019. HGH is human growth hormone. IFN is interferon. A hyphen indicates
that a product was not launched. Sources: 2008 sales data are from MIDAS, IMS Health, March 2009; forecast for 2009–2019 is
from Datamonitor. (FIGURE COURTESY OF THE AUTHOR)
To date, three biosimilars have entered the European market: somatropin, epoetin alpha, and granulocyte-colony stimula-ting
factor. These products have yet to have a significant effect on the market, however. Despite this slow start, biosimilars
are expected to garner peak sales of $2 billion in 2014 in the seven major markets (1). Given that major-market sales of branded
epoetin market totaled $9.9 billion in 2008, it is not surprising that biosimilar epoetin alpha is forecast to dominate the
biosimilars market. Biosimilar insulin-glargine is expected to be the second-largest product. Yet, with the exception of insulin-glargine,
the biosimilars uptake is forecast to decline after 2014, primarily because second-generation biosimilars will enter the market
at that time (see Figure 1).
One of the major advantages of epoetin alpha is that it is a small, simple biologic (it contains 165 amino acids), with a
relatively inexpensive and well-established manufacturing process. These considerations facilitate molecule development and
characterization and therefore reduce perceived risk.
In contrast, standard human insulin is a poor commercial prospect for biosimilars because new insulin analogs are available.
But human insulin biosimilars may provide an attractive market entry point for companies that plan to build a reputation in
diabetes treatment as part of a long-term strategy. Standard human insulin does not have patent protection and, as one of
the simplest and best-characterized biologics, it is simple and inexpensive to manufacture. In fact, numerous companies in
the emerging markets of Eastern Europe, India, and China already market generic human insulin. In 2008, the insulin-analog
market was worth $7.2 billion and accounted for 77% of all insulin sales in the seven major markets (2). This market is a
lucrative opportunity for biosimilars companies. sanofi aventis's (Paris) long-acting Lantus (insulin-glargine), which represented
38% of all seven major markets' sales of insulin analogs in 2008, is the most lucrative product in this class. Datamonitor
anticipates that biosimilars for this product will enter the market first in the US and Germany in 2014. Adoption of biosimilars
in these markets and in the UK is predicted to result in peak sales of $530 million by 2019.