Erythropoietins: the shift from biosimilars to “more for less” ESAs

Despite stagnant erythropoietin (EPO) sales, four new EPO products were introduced in Europe during the last year, but the pipeline shifts from biosimilar based approaches to next generation erythropoiesis stimulating agents (ESA)

Barcelona, Spain | July 23, 2008 | The Business Intelligence firm La Merie S.L. reported that for the first time sales of major erythropoietin products declined to US$ 11.8 bln in 2007, down by US$ 100 mln from the previous year. Additionally, four new epoetin based products were launched in European countries, among them two biosimilars, epoetin delta produced in a human cell line and Roche’s pegylated version of epoetin beta. Concerns about overusage and safety are expected to further cause a decline of erythropoietin sales in the major markets. Nevertheless, the huge potential of the erythropoietin market still attracts an ever increasing number of competitors. While the pipeline of first generation epoetin biosimilars is stagnant, new technologies stimulate the pipeline of next generation products with at least seven in clinical evaluation and 25 in preclinical R&D. These results and more were found in a search conducted by La Merie Business Intelligence. The evaluation can be acquired at La Merie’s online store (www.pipelinereview.com/store ).

The report provides information on the pipeline of epoetin biosimilars currently in development for highly regulated markets. The marketed biosimilar products currently are priced at 25 to 30 % less than the previous originator price which hardly is convincing prescribing physicians so far. Key success factors for next generation ESAs are technology platforms, the market presence and portfolio as well as the low cost position of the company overall in order to successfully launch an ESA with better clinical features for less money (“more for less”). Teva’s recent acquisition of CoGenesys exemplifies this policy. The albumin fusion technology allows to cost-efficiently produce ESAs and other biosimilars with a prolonged half-life to be marketed by the leading generics company. The report compiles in a tabulated format next generation ESAs which include engineered proteins, fusion proteins, conjugated and dimeric peptides, antibodies, small molecules, gene therapy approaches and new expression technologies. The report also provides an overview on the worldwide manufacturers of recombinant epoetin in off-patent countries.

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SOURCE: La Merie