Biogen and Samsung Bioepis announce the European launch of IMRALDITM, an adalimumab biosimilar referencing HUMIRA®.
The launch of IMRALDI™ across Europe marks a significant milestone for Biogen and Samsung Bioepis, as the adalimumab biosimilar product is the third anti-TNF biosimilar developed by Samsung Bioepis to be commercialised by Biogen across Europe.
BENEPALI™ (etanercept) and FLIXABI™ (infliximab) were approved in 2016, and have approximately 100,000 patients currently under treatment with more than 6 million doses administered across 25 and 14 countries, respectively.
The European Commission (EC) approved IMRALDI™ in August 2017 for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and uveitis.
“We hope IMRALDI will play an important role widening choice and increasing competition in one of the most high-value areas of the biopharmaceuticals market.”
The EC approval was based on data derived from a randomised, double-blind 52-week Phase 3 study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy were randomised to receive either SB5 or the adalimumab reference product (ADL). At Week 24, the ACR20 response rate was 72.4% in the SB5 group versus 72.2% in the ADL group. The safety profile of SB5 was comparable to ADL up to Week 24.
At Week 24, 254 patients receiving ADL were re-randomised in a 1:1 ratio to continue on ADL or transitioned to SB5, and 254 patients receiving SB5 continued to receive SB5. Up to Week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups.
Ian Henshaw, Head of Biogen’s Biosimilars Unit said, “We look forward to increasing patient access to this important medicine by leveraging our industry-leading position in the European anti-TNF market.”
Sang-Jin Pak, Chief Operating Officer, Samsung Bioepis said “The launch of IMRALDI marks what we believe to be a landmark moment for Biogen and Samsung Bioepis and for European healthcare systems. We hope IMRALDI will play an important role widening choice and increasing competition in one of the most high-value areas of the biopharmaceuticals market.”
“We are proud of our collaboration with Biogen, which brings together the development expertise of Samsung Bioepis with the commercial excellence of Biogen for the benefit of patients across Europe.”