EU CHMP OKs Imraldi, Samsung Bioepis’ Biosimilar Of AbbVie’s Humira
Executive Summary
The EU’s CHMP has given the green light to Imraldi, Samsung Bioepis’ biosimilar version of AbbVie’s blockbuster adalimumab product Humira. If approved by the European Commission, this will be the South Korean company’s third biosimilar anti-TNF alpha product to gain a marketing authorization in the EU.
The European Medicines Agency’s scientific committee, the CHMP, has recommended approval of Samsung Bioepis Co. Ltd.’s Imraldi (SB5), a biosimilar version of AbbVie Inc.’s blockbuster TNF-alpha inhibitor, Humira (adalimumab).
The product was OKd for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis.
The Imraldi submission was accepted by the EMA just under a year ago, in July 2016. The company said at the time that the EU approval application was based on results of a 52-week Phase III study which randomized 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy and showed SB5’s comparable efficacy and safety to Humira among different treatment groups. (Also see "EU’s CHMP Expected To OK Another Biosimilar Humira" - Scrip, 22 Jun, 2017.)
Imraldi now goes to the European Commission for a decision on marketing authorization, which should come within two or three months. If approved, it will be the South Korean company’s third anti-TNF-alpha biosimilar in Europe. Marketing and distribution of the product in Europe will be handled by Samsung Bioepis’ commercialization partner, Biogen Inc.
Amgen Inc. was the first company to gain EU approval for biosimilar adalimumab when its products Amgevita and Solymbic were authorized for marketing by the European Commission in March this year.