EMA Committee Urges Approval of Humira Biosimilar Imraldi to Treat IBDs

EMA Committee Urges Approval of Humira Biosimilar Imraldi to Treat IBDs
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding on marketing authorization for Imraldi (adalimumab), a biosimilar candidate referencing Humira. The EMA committee recommended Imraldi for the treatment of inflammatory bowel diseases (IBDs) like Crohn’s disease, pediatric Crohn’s disease and ulcerative colitis, as well as rheumatoid arthritis, psoriatic arthritis and psoriasis, among others. The positive opinion will now be reviewed by the European Commission, which will vote whether to authorize the drug for marketing. If granted, Biogen will be responsible for commercializating Imraldi in the 28-member European Union. “We welcome the EMA’s positive recommendation for Imraldi, which brings us a step closer to delivering a lower-cost, high-quality autoimmune treatment option to patients across Europe,” Christopher Hansung Ko, president and CEO of Samsung Bioepis, said in a press release. “Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more patients and healthcare systems across Europe will benefit from biosimilars.” Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen, and is the partnership behind the discovery and development of Imraldi. The marketing authorization application for Imraldi was supported by data resulting from a Phase 3 trial (NCT02167139), in which 544 patients with moderate-to-severe rheumatoid arthritis, after treatment with methotrexate (MTX), were randomized to receive either Imraldi or Humira. At week 24, ACR20 response rate was 72.4 percent for the Imraldi group versus 72.2 percent for the
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