IMRALDITMâ–¼, BIOGENâ€™S ADALIMUMAB BIOSIMILAR REFERENCING HUMIRAÂ®, IS LAUNCHED IN THE EUROPEAN UNION
Maidenhead, UK – 17th October, 2018 - Samsung Bioepis Co. Ltd, a joint venture between Samsung BioLogics and Biogen (Nasdaq: BIIB) today announced the European launch of IMRALDI, an adalimumab biosimilar referencing Humira®.
IMRALDI is approved in Europe for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis; enthesitis-related arthritis), axial spondyloarthritis (ankylosing spondylitis (AS); axial spondyloarthritis with radiographic evidence of AS), psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, paediatric Crohn's disease, ulcerative, uveitis.
The launch of IMRALDI completes Biogen’s portfolio of three anti-TNF biosimilars in Europe, with BENEPALITMâ–¼ (etanercept), a biosimilar referencing Enbrel®, and FLIXABITMâ–¼ (infliximab), a biosimilar referencing Remicade®, reinforcing the company’s commitment across therapeutic areas in rheumatology, gastroenterology and dermatology.
“We are proud to be pioneering innovation in biosimilars to help transform the lives of people in the UK with chronic autoimmune conditions,” said Dan Cohen, Regional Director of Biogen UK, Ireland & Netherlands. “With the addition of IMRALDI to our anti-TNF biosimilar offering, we are increasing clinician choice and patient access in the UK to affordable treatments across disease areas.”
IMRALDI has demonstrated equivalent pharmacokinetics (PK (phase I trial)) and efficacy (American College of Rheumatology (ACR) 20 at 24 weeks in the phase III trial) together with comparable safety and immunogenicity with the reference product, whilst offering a greater shelf life of three years compared to two years for Humira. IMRALDI offers a 40mg/0.8 ml formulation, which is the same volume as the original Humira formulation. In addition, Biogen offers a flexible homecare service to support patients and clinicians. Biogen has nearly 40 years of experience of developing, manufacturing and commercialising advanced biologic medicines across Europe via its state-of-the-art manufacturing global network. Biogen now has an EU-approved portfolio that includes three of the most widely prescribed anti-TNF biosimilars, with BENEPALI available in 25 countries and FLIXABI available in 14 countries.
About IMRALDI Clinical Trials
The European Commission approval was based on a preclinical and clinical data package comparing IMRALDI with Humira. The clinical data include results from two head-to-head studies – a Phase I study in healthy volunteers that demonstrated pharmacokinetic bioequivalence to Humira and a 52 week Phase III, randomised, double-blind, multicentre study, in which IMRALDI demonstrated comparable efficacy and comparable safety and immunogenicity to Humira in patients with moderate to severe RA despite methotrexate therapy. The primary endpoint of the Phase III study, 20% (ACR20) response at Week 24, was met, demonstrating equivalent efficacy to Humira (ACR20 response rate was 72.4% in the IMRALDI group versus 72.2% in the Humira group (adjusted difference of 0.1%, [95% confidence interval -7.83%, 8.13%]). Between Week 24 and Week 52, in 125 patients who were switched from Humira to IMRALDI, efficacy, safety, and immunogenicity profiles were found to be comparable to those in patients who remained on Humira (129) or IMRALDI (254) during the transition period.
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 a 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 programmes in Alzheimer’s disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry and acute neurology. Biogen also manufactures and commercialises biosimilars of advanced biologics.
To learn more, please visit www.biogen.uk.com.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realising accessible healthcare. 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.