Roche plans to launch its anemia drug Mircera immediately in the U.K. and Germany, company officials said today. The news follows yesterday’s E.U. approval of the drug, in a single marketing authorization valid for al. 27 member E.U. states. Mircera is Roche’s follow-up to NeoRecormon which will soon lose patent protection, and analysts expect Mircera to quickly overtake NeoRecormon and other epoetin-stimulating drugs on the market because its monthly doses are seen as an advantage over the weekly doses required by competing medications.
The approval, while expected, could usher in a shake-up in the epo market in Europe, as the drug class becomes the first biologic to face generic competition. Last month the E.U. recommended approval of a generic epoetin alfa by Sandoz, the generic unit of Novarits. Approval is expected later this year. In the U.S., the FDA issued Roche an “approvable†letter for Mircera, meaning the drug could be approved once certain conditions are met
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