GTC Biotherapeutics (fka GTCB)

[gym gravity]

FOB news in EU

http://www.reuters.com/article/marketsNews/idUKN2128141520080221?rpc=44

UPDATE 1-Teva, others win EU okay for biosimilar Neupogen
Thu Feb 21, 2008 12:51pm EST (Adds Neupogen sales figure)

LONDON, Feb 21 (Reuters) - The European Medicines Agency has recommended approval of four biosimilar versions of Neupogen, Amgen's (AMGN.O: Quote, Profile, Research) best-selling treatment for neutropenia.

The London-based watchdog said on Thursday it had approved four drugs defined as biosimilars for the original product -- Tevagrastim, from Teva (TEVA.O: Quote, Profile, Research); Ratiograstim and Filgrastim, from ratiopharm; and Biograstim, from CT Arzneimittel.

Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

Neupogen, used to boost white blood cells in patients on chemotherapy, had sales of about $300 million in the EU for the 12 months ended Sept. 30, 2007, according to data compiled by IMS Health (RX.N: Quote, Profile, Research), Teva said. (Reporting by Ben Hirschler; Editing by Brian Moss)