Posted by Michael Wonder on 19 Dec 2017
Fresenius submits first biosimilar marketing authorisation application
18 December 2017 - Fresenius Kabi has submitted a marketing authorisation application to the EMA for its adalimumab biosimilar candidate of Humira.
The application is the first biosimilar regulatory filing for Fresenius Kabi. Adalimumab is approved in the EU for use in the treatment of chronic inflammatory auto-immune conditions, including different types of arthritis or Crohn's disease.
