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 biosi.0milar products have been approved in the EU: Amgen’s AmgevitaTM and Solymbic, Samsung Bioepis’s Imraldi®, and Boehringer Ingelheim’s Cyltezo®.