Biogen and Samsung BioLogics receive EU approval for Imraldi

Biogen and Samsung BioLogics have announced that their new adalimumab biosimilar therapy Imraldi has been approved by the European Commission.

The drug is based on AbbVie's Humira and has been approved in the same indications, including rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, paediatric Crohn's disease, ulcerative colitis and uveitis.

Imraldi has been developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen, and has demonstrated comparable efficacy, safety and immunogenicity to Humira across a number of clinical trials.

This is the third anti-TNF biosimilar from Biogen to be approved in Europe, following the ratification of the Enbrel-based Benepali and the Remicade biosimilar Flixabi in 2016.

Jean-Paul Kress, international executive vice-president and head of global therapeutic operations at Biogen, said: "Today's decision marks another positive step in transforming the lives of people with chronic autoimmune conditions. As the number of approved biosimilars continues to grow, so does the anticipated potential to increase physician choice and patient access to biologics."

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