Exclusivity for biologicals in Europe is around 11 years, comprising 10 years for new biologics (8-year data exclusivity and 2-year market exclusivity) and a 1-year extension for a new indication.

According to researchers at Frost & Sullivan, the European biosimilars market generated revenues of approximately US$172 million in 2010 and is expected to reach almost US$4 billion by 2017.

Biosimilars marketed in Europe fall into three product classes: human growth hormone, granulyte colony-stimulating factor (G-CSF) and erythropoietin, see Table 1.

Table 1: Biologicals and biosimilars marketed in Europe

*Only marketed in Germany.
HGH: human growth hormone; G-CSF: granulyte colony-stimulating factor; EPO: erythropoietin; J&J: Johnson and Johnson.

Biosimilars only make up about 7% of the HGH market in Europe and 12% of the erythropoietin market, whereas they have made a significant impact on the G-CSF market, making up 40% of the market in terms of defined daily doses.

Uptake of biosimilars varies considerably between different countries within Europe, with some countries having a better acceptance of biosimilars than others, see Figure 1.

Figure 1: Use of biosimilars per head of population in Europe

*IMS data covers the retail channel only; **IMS data combined hospital and retail audit.
Source: IMS MIDAS 2011

In the current climate of government cost savings and what with the high cost of biological drugs adoption of biosimilars is a key issue. In the future, European countries have to focus on how to increase trust in biosimilars, thus increasing their acceptance and use.

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