Drug news
European Commission approves Idacio an adalimumab biosimilar.- Fresenius Kabi
The European Commission (EC) has granted Fresenius Kabi the marketing authorization for Idacio, an adalimumab biosimilar, for all indications of the reference medicine. With this EC approval, Idacio is the first approved molecule of the Fresenius Kabi biosimilars portfolio.
The EC approval of IDACIO was based on the totality-of-evidence detailed in the comprehensive data package submitted to the European Medicines Agency (EMA) including analytical, preclinical and clinical data in healthy volunteers and patients.