Fresenius Kabi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending marketing authorization for MSB11022 a biosimilar candidate of Humira® (adalimumab)*. The European Commission (EC) will now decide on the approval of MSB11022 which is expected in Q2/ 2019.
*Humira® is a registered trademark of AbbVie Biotechnology Ltd.