This article is more than 5 years old. Information may no longer be current.
EMA recommends approval of Humira biosimilar Imraldi
Click Here to Manage Email Alerts
The European Medicines Agency has recommended the approval of the Imraldi, making it the third anti-TNF biosimilar candidate to receive a positive opinion from the Committee for Medicinal Products for Human Use, the manufacturer announced.
Imraldi (SB5, Samsung Bioepis) is a biosimilar candidate referencing Humira (adalimumab, AbbVie), indicated for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hydradentis suppurativa, Crohn’s disease in adults and children, ulcerative colitis and uveitis.
Christopher Hansung Ko
The recommendation “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, a joint venture between Samsung BioLogics and Biogen, 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 health care systems across Europe will benefit from biosimilars.”
The drug’s Marketing Authorization Application — which the EMA accepted for review in July of last year — is supported by a clinical package comparing Imraldi and Humira, including data from a phase 3 double blind, multicenter randomized trial, in which 544 patients with moderate-to-severe rheumatoid arthritis despite methotrexate received either the biosimilar or the reference product for 52 weeks.
Response rates (72.4% in the biosimilar group vs. 72.2% in the adalimumab group) and safety were comparable at week 24. At this point, the trial researchers randomly assigned 254 patients in each group to either switch agents or remain on the same treatment, after which safety, efficacy and immunogenicity remained comparable across the three treatment groups through 52 weeks. Switching resulted in no “treatment emergent issues or clinically relevant immunogenicity.”
The clinical package also includes data from a phase 1 head-to-head study in healthy volunteers that showed pharmacokinetic bioequivalence between the biosimilar and reference product.
The CHMP’s recommendation will be referred to the European Commission, and if approved, Biogen will commercialize Imraldi in the European Union, according to the press release.
Samsung Bioepis also submitted an application for marketing approval in Korea in August of last year, according to the company’s website.
Humira is the most prescribed biologic in the world with global sales reaching $16 billion in 2017, and nearly half of the $9 billion spent on anti-TNF therapies in Europe is spent on Humira, according to a press release from Biogen. Introducing biosimilars of the top three anti-TNF therapies could save Europe $11.44 billion by 2020, of which $3.18 billion could be attributed to biosimilar adalimumab, according to data presented at the International Society for Pharmacoeconomics and Outcomes Research meeting in Boston earlier this year.
“If Imraldi receives approval, Biogen will be the first company to have approved biosimilars of the three most prescribed anti-TNF biologic treatments in Europe,” Alpna Seth, PhD, senior vice president and global head of the biosimilars business unit at Biogen, said in the press release. “Being able to provide this range of anti-TNF treatment alternatives bolsters our leadership position and underscores our commitment to expanding physician choice, while supporting the sustainability of health care systems.” – by Adam Leitenberger
Disclosures: Ko is employed by Samsung Bioepis and Seth is employed by Biogen.