Too many companies with biogeneric G-CSF products compete for a small market

Released on = October 17, 2005, 3:37 am

Press Release Author = La Merie Business Intelligence PR

Industry = Biotech

Press Release Summary = More than 20 additional companies with activites in the biogeneric field of G-CSF were identified in a search conducted by La Merie Business Intelligence.

Press Release Body = Barcelona, October 17, 2005

Amgen’s strategy to substitute its first generation granulocyte – colony stimulating factor (G-CSF) product Neupogen (filgrastim) by the longer acting, pegylated G-CSF product Neulasta (pegfilgrastim) appears to be successful in protecting its US$ 2.9 bln combined global sales in 2004. The year 2004 conversion rate of 60 % for
Neulasta (in its second year after approval) suggests that only a very small market will be left over for the five European companies with biosimilar versions of G-CSF when only the European patent expires in 2006. More than 20 additional companies with activites in the biogeneric field of G-CSF were identified in a search conducted by La Merie Business Intelligence. The results were published in the
October 17 issue of R&D Pipeline News, edited by La Merie.

Biotechnology initiatives in India and China have lead to more than 20 domestic manufacturers of G-CSF and GM-CSF in China and at least seven Indian companies with proprietary manufacturing. As the domestic markets are too small (e.g. Indian market size of only US$ 25 mln due to low price products), Asian companies are
collaborating with Western enterprises (GeneMedix, BioPartners and Dragon Pharmaceuticals) to pass the financial, regulatory and quality barriers and catch a piece of the Western market. South American manufacturers of G-CSF so far are exporting to developing countries only.

The real biogeneric challenge for established G-CSF marketers will come with patent expiry of pegylated G-CSF in 2013/15. So far, predominantly North American companies are working on next generation G-CSF products with longer half-life and increased
efficacy. All of these projects still are in preclinical stages of R&D. G-CSF so far is indicated for prevention and treatment of neutropenia mainly due to chemotherapy. Berlex (US-subsidiary of Schering AG) is in advanced clinical development of its GM-CSF product for treatment of Crohn’s disease which could more than double its sales once approved for this up side indication.

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