Reuters: Regulatory News: Celltrion's biosimilar Remicade gets EU green light

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Celltrion's biosimilar Remicade gets EU green light Jun 28th 2013, 11:53 LONDON, June 28 | Fri Jun 28, 2013 7:53am EDT LONDON, June 28 (Reuters) - European regulators have recommended approval of a copycat version of the blockbuster rheumatoid arthritis drug Remicade, the first time a green light has been given for such an antibody-based medicine. The European Medicines Agency said on Friday its experts had backed approval of Remsima, made by South Korea's Celltrion , which is a so-called biosimilar version of Johnson & Johnson and Merck & Co's injectable drug. 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. The European Medicine's Agency also recommended approval for Hospira's Inflectra, which is also a biosimilar version of Remicade.

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