Biogen and Samsung Bioepis Announce European Launch of IMRALDI(adalimumab), Solidifying Leadership in European Anti-TNF Market
Biogen (Nasdaq:BIIB) and Samsung Bioepis Co., Ltd. today announced the European launch of IMRALDI (adalimumab), a biosimilar referencing HUMIRA. Starting today, IMRALDI will begin launching in major markets across Europe.
The launch of IMRALDI marks a significant milestone for Biogen and Samsung Bioepis, as the adalimumab product is the third anti-TNF biosimilar developed by Samsung Bioepis to be commercialized 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.ii
“We look forward to increasing patient access to this important medicine by leveraging our industry-leading position in the European anti-TNF market,” said Ian Henshaw, Head of Biogen’s Biosimilars Unit.
“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,” said Sang-Jin Pak, Chief Operating Officer, Samsung Bioepis. “In just six years, Samsung Bioepis has successfully developed the industry’s leading portfolio of anti-TNF biosimilars with a strong pipeline of further biosimilar candidates currently under development.”
“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.”
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.iii
The EC approval was based on data derived from a randomized, double-blind 52-week Phase 3 study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX)
therapy were randomized 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-randomized 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. There were no treatment emergent issues or
clinically relevant immunogenicity precipitated by alternating subjects between treatments.iv v
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics.
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About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology and ophthalmology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.