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BioWorld - Tuesday, March 9, 2021
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Home » Samsung Bioepis lands positive CHMP opinion for Enbrel biosimilar
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Samsung Bioepis lands positive CHMP opinion for Enbrel biosimilar

Nov. 25, 2015
By Michael Fitzhugh
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Plans to launch the first biosimilar of Enbrel (etanercept, Amgen Inc.) in Europe are taking a big step forward with receipt by Samsung Bioepis Co. Ltd. of a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP). If approved by the European Commission (EC) as expected, it would become the first subcutaneous anti-TNF biosimilar there. It is one of three Bioepis biosimilars that Biogen Inc. has rights to commercialize in the EU and other countries.
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