Regulatory Affairs

European Medicines Agency recommends approval of Humira biosimilar Imraldi

PBR Staff Writer Published 26 June 2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis' Imraldi for approval, which is a biosimilar candidate referencing Humira (adalimumab).

Imraldi has been recommended to be approved for rheumatoid arthritis, 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.

The CHMP’s positive opinion will be reviewed by the European Commission (EC) to grant a marketing authorization for Imraldi.

Biogen will market Imraldi in the European Union states if it is approved by the EC.

The recommendation for approval was based on data collected derived from a randomized and double-blind 52-week Phase III study, in which 544 patients were recruited.

The patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy have been randomized to secure either Imraldi or the adalimumab reference product (ADL).

According to the company, the the ACR20 response rate was 72.4% in the Imraldi group versus 72.2% in the ADL group at week 24.

Samsung Bioepis president and CEO Christopher Hansung Ko said: “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.

“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, which is a joint venture of Samsung BioLogics and Biogen, has six first-wave candidates, which cover the therapeutic areas of immunology, oncology and diabetes.

Image: Samsung Bioepis headquarters in Incheon, Korea. Photo: courtesy of Business Wire.