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Imminent launches of new EPO products and consolidation of the biogenerics field

Posted on: 02 Jun 06


Three European launches of new EPO products to be expected within two years; full pipeline of biogeneric and innovator EPO products

BARCELONA, Spain | June 02, 2006 | The Business Intelligence firm La Merie S.L. reported today changes in the field of erythropoiesis stimulating agents (ESA) observed in a follow-up analysis. The first launch of a new ESA in Europe is expected to be Shire’s epoetin omega in the first half of 2007 to be followed by Roche’s next generation pegylated erythropoietin (EPO) product CERA in the second half of 2007. As the filing of the first biogeneric EPO with the EMEA by Stada’s Bioceuticals subsidiary is scheduled in June 2006, its European launch is expected for the first half of 2008. First approvals of biogeneric hGH and the EMEA guidance of biogeneric development by scientific advice and specific guidelines contribute to the consolidation of the biogeneric EPO field. Some players left the field due to higher than expected costs of development, while others are concluding marketing partnerships throughout Europe after reduction of the regulatory risk. These results and more were found in a search conducted by La Merie Business Intelligence. The follow-up competitor analysis can be acquired at, La Merie’s News Center and Online Store. More information will be provided in the biogenerics miniseries published in the FREE daily R&D Newsletter of beginning June 19, 2006.


Global sales of EPO products again exceeded US$ 11 bln in 2005, but did not further increase compared with 2004. Sales of first generation epoetin alfa by Amgen (-6 %) and J&J (- 7 %) are successively being converted into sales of longer-acting darbepoetin alfa (+ 32%) from Amgen. The European EPO market accounts only for 20-25 % of the total EPO market, but is exposed to a series of new EPO launches over the next years and a full pipeline of generic EPO developments. In addition, five next generation ESAs are in clinical development stages and include at least two oral small molecules. The acquisition of European licensing rights of FG-2216 by Astellas from Fibrogen validates the oral ESA approach. At least ten further innovator ESAs are in non-clinical stages.


An increasing number of companies have established EPO manufacturing capacity in “off-patent” countries such as India and China and are offering low cost national alternatives to expensive branded products. In contrast, the first biogeneric products in Europe and the US are to be sold at a 25-30 % discount to the original products. Asian companies are also entering successively the innovator field with next generation ESAs.



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SOURCE: La Merie Business Intelligence

La Merie Business Intelligence

Last updated on: 27/08/2010 11:40:18

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