Fresenius Kabi Announces Submission of Application for Biosimilar of Humira (Adalimumab)

EMA News

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 AmgevitaTM and Solymbic, Samsung Bioepis’s Imraldi®, and Boehringer Ingelheim’s Cyltezo®.

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