Biogen’s adalimumab biosimilar referencing Humira, is approved in the EU

Biogen becomes the first company with approved biosimilars for the three most prescribed anti-TNF biologic treatments in Europe.

Imraldi has been developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen and is approved for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis.

ImraldiI is the third anti-TNF biosimilar from Biogen to receive a marketing authorization in the European Union (EU) following the approval in 2016 of Benepali (etanercept), a biosimilar referencing Enbrel, and Flixabi (infliximab), a biosimilar referencing Remicade. Anti-TNF therapies represent some of the EU’s largest drug expenditures, costing an estimated $9 billion (€8 billion) each year from 2011 to 2014.4,5 Introducing biosimilars of the top three anti-TNF therapies in Europe could lead to estimated potential savings of up to $11.44 billion (€9.69 billion), between the patent expiry date of each reference product and 2020.5,6 With the approval of IMRALDI, Biogen has become the first company to have approved biosimilars for all three of these therapies.

“Today’s decision marks another positive step in transforming the lives of people with chronic autoimmune conditions,” said Jean-Paul Kress, EVP International and Head of Global Therapeutic Operations, Biogen. “As the number of approved biosimilars continues to grow, so does the anticipated potential to increase physician choice and patient access to biologics.”