Fresenius Kabi today announced it has submitted an application seeking marketing authorization for its biosimilar version of Humira® (adalimumab) in the EU.  This is Fresenius Kabi’s first biosimilar regulatory filing.

Four adalimumab biosimilar products have been approved in the EU:  Amgen’s Amgevita^TM and Solymbic, Samsung Bioepis’s Imraldi®, and Boehringer Ingelheim’s Cyltezo®.