The European Commission has approved Imraldi, an adalimumab biosimilar referencing AbbVie’s Humira — making the medication available to treat the same therapeutic indications as Humira, including Crohn’s disease, pediatric Crohn’s disease and ulcerative colitis.
The Aug. 24 decision followed a positive recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use, released in June.
“Today’s decision marks another positive step in transforming the lives of people with chronic autoimmune conditions,” Jean-Paul Kress, Biogen’s executive vice-president and head of global therapeutic operations, said in a press release. “As the number of approved biosimilars continues to grow, so does the anticipated potential to increase physician choice and patient access to biologics.”
Imraldi was developed by Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics. It is Biogen’s tgurd anti-TNF biosimilar medicine to receive European marketing approval following Benepali, an etanercept biosimilar referencing Enbrel, and Flixabi, an infliximab biosimilar referencing Remicade.
The approval was supported by strong preclinical and clinical data demonstrating Imraldi’s safety and efficacy profiles. Clinical data included results from a Phase 1 trial (NCT02144714) in healthy volunteers, and a Phase 3 study (NCT02167139) in rheumatoid arthritis patients that compared Imraldi with Humira.
That Phase 3 trial of 544 patients with moderate-to-severe rheumatoid arthritis showed that 40 mg every other week via subcutaneous injection of each medicine over 24 weeks improved symptoms by 20 percent in about 72 percent of patients in each treatment group, despite methotrexate therapy.
Following this treatment period and up until week 52, some patients were switched from Humira to Imraldi. This change did not induced any immune reaction, further confirming the similarities between the two medicines.
Imraldi will be available for any patient older than 6 years of age with moderate-to-severe active Crohn’s disease who have not responded to corticosteroid or immunosuppressant treatment regimens, or who cannot tolerate standard-of-care therapies. Imraldi will also be approved to treat adult patients moderate-to-severe ulcerative colitis who do not respond to first-line of therapy with corticosteroids and Purinethol (6-mercaptopurine) or Azasan (azathioprine), who are intolerant, or who have medical contraindications for such treatments.
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