Roche plans to launch its anemia drug Mircera immediately in the U.K. and Germany, company officials said today. The news follows yesterdayâ€™s E.U. approval of the drug, in a single marketing authorization valid for al. 27 member E.U. states. Mircera is Rocheâ€™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 â€œapprovableâ€ letter for Mircera, meaning the drug could be approved once certain conditions are met
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