UPDATE 2-Teva, others win EU okay for biosimilar Neupogen
(Adds Teva executive quote, background on market)
LONDON, Feb 21 (Reuters) - The European Medicines Agency has recommended approval of four biosimilar versions of Neupogen, Amgen's (AMGN.O) best-selling treatment for neutropenia, marking a further opening of the biotech drug market to generic copies.
The London-based watchdog said on Thursday it backed four drugs defined as biosimilar forms of the original product -- Tevagrastim, from Teva (TEVA.O); 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 European Union for the 12 months ended Sept. 30, 2007, according to data compiled by IMS Health (RX.N), Teva said.
Neupogen is a biotechnology medicine and, as such, contains proteins that are much more difficult to replicate than conventional synthetic pharmaceutical compounds.
Because of their complexity, regulators have been wary about approving generic versions of biotech drugs, although Europe has been more advanced in giving a green light than the United States.
European officials have already given approved biosimilar forms of the anaemia drug EPO and human growth hormone.
For generic drugmakers, biotech drugs represent an enticing market opportunity -- especially as prices for such products are expected to be only 25 to 40 percent below those of original brands, according to the European Generic Medicines Association.
The price of conventional easy-to-make generic drugs can quickly fall to a 90 percent discount to the original.
Amir Elstein, Teva's head of global resources, said the biosimilar, or biogeneric, arena was a priority for his group, which is the world's largest generic drugmaker.
"Coupled with our recent acquisition of CoGenesys, which significantly enhances our capabilities, our strong biogeneric pipeline reflects our determination to capture the considerable long-term prospects we believe the biogeneric market will offer," he said in a statement.
(Editing by Rory Channing)
