Fresenius Kabi receives European Commission approval for adalimumab biosimilar IDACIO®

IDACIO®* is Fresenius Kabi's first biosimilar approved by the European Commission for indications in the areas of rheumatology, gastroenterology and dermatology.

May 17, 2019 

Fresenius Kabi, a global healthcare company that specialises in lifesaving medicines and technologies, are pleased to announce that the European Commission (EC) granted marketing authorisation for IDACIO®, an adalimumab biosimilar. 

"Fresenius Kabi has a heritage of providing high-quality and affordable products to patients and the EC approval of IDACIO® is an exciting achievement for us, leading to our first entry into the European biosimilars market." said Dr. Michael SchÖnhofen, Member of the Fresenius Kabi Management Board and President of the Pharmaceuticals and Devices Division. "We are devoted to putting patients first, and we will focus our efforts to ensure patients access to IDACIO® within Europe."

IDACIO® is the first approved molecule of the Fresenius Kabi biosimilars porfolio with a focus on autoimmune and oncology medicines. The EC approval of IDACIO® is an important milestone for Fresenius Kabi as a company, contributing to the advances in patient care, and for those who need alternative affordable treatment options. 


IDACIO® was developed by Fresenius Kabi. The European Commission approved IDACIO® for the treatment of rheuatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis including ankylosing spondylitis, psoriatic arthritis, adult and paediatric, plaque psoriasis, adult and adolescent hidradenitis suppurativa, adult and paediatric Crohns's disease, ulcerative colitis, adult and paediatric non-infectious uveitis4.

4 SmPC data on file