Samsung Bioepis has become only the second firm to gain a European Medicines Agency endorsement for its denosumab biosimilars to Prolia and Xgeva, with the agency’s Committee for Medicinal Products for Human Use issuing positive opinions for the company’s rival versions under the names Obodence and Xbryk.
While CHMP positive opinions do not constitute formal approval, the European Commission typically acts to convert them into pan-European marketing authorizations with 67 days.
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