In August 2017, the European Commission approved the use of Imraldi for the same indications as Humira, which include a range of inflammatory conditions such as juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, psoriasis, axial spondyloarthritis, ulcerative colitis, and Crohn’s disease.
The biosimilar is now coming available in major markets within all 28 countries of the European Union.
Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. The launch of Imraldi increases Biogen’s portfolio to three anti-TNF biosimilars in Europe. The other two include Benepali (etanercept), a biosimilar of Enbrel, and Flixabi (infliximab), a biosimilar of Remicade.
“We are proud to be pioneering innovation in biosimilars to help transform the lives of people in Europe with chronic autoimmune conditions,” Ian Henshaw, global head of biosimilars at Biogen, said in a press release. “With the addition of Imraldi to our anti-TNF biosimilar offering, we are increasing physician choice and patient access in Europe to affordable treatments across disease areas.”
A biosimilar is a biological product similar to an already approved medication, known as the reference product, and proven to be equivalent in terms of safety, quality, and effectiveness.
Like Humira, Imraldi is an anti-inflammatory agent that inhibits tumor necrosis factor alpha (TNF), a protein of the immune system that promotes inflammation. The European Medicines Agency’s approval of the therapy was based on the success of preclinical and clinical studies comparing its efficacy to that of Humira.
In particular, a Phase 1 clinical trial (NCT02144714) compared the pharmacokinetic profile (how the body processes a medication upon administration) of Imraldi to Humira in healthy volunteers and showed that the two therapies had a similar profile.
In a Phase 3 trial (NCT02167139), 544 patients with moderate to severe rheumatoid arthritis who did not respond to the standard methotrexate treatment were randomly assigned to receive either Imraldi (271 patients) or Humira (273 patients). After 24 weeks of treatment, both Imraldi- and Humira-treated patients responded favorably to the treatment with no significant difference in regards to efficacy, safety, and ability to invoke an immune response.