The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 June 2017 that it had recommended granting marketing authorization for the adalimumab biosimilar Imraldi from Samsung Bioepis.
Imraldi was recommended for approval for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and uveitis.
The recommendation is based on a preclinical and clinical data package comparing Imraldi with the reference product, AbbVie’s Humira (adalimumab). The clinical data included results from two head-to-head studies – a phase I study in healthy volunteers that, according to Biogen, ‘demonstrated pharmacokinetic bioequivalence to Humira’ and a phase III, randomized, double-blind, multicentre study, in which, according to Biogen, ‘Imraldi demonstrated equivalent efficacy and comparable safety and immunogenicity to Humira in patients with rheumatoid arthritis’. The company added that ‘the primary endpoint of the phase III study, the American College of Rheumatology 20% (ACR20) response at Week 24, was met, demonstrating equivalent efficacy to Humira. Secondary endpoints demonstrated that Imraldi has a comparable safety and immunogenicity profile to Humira’ [1].
Samsung Bioepis, which is a joint venture between biotechnology company Biogen and South Korean electronics giant Samsung, already has two biosimilars approved by EMA. Benepali (etanercept) was approved in January 2016 and Flixabi (infliximab) was approved in May 2016 [2].
The positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union (EU).
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References
1. GaBI Online - Generics and Biosimilars Initiative. Phase III results of adalimumab biosimilar demonstrate equivalence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 30]. Available from: www.gabionline.net/Biosimilars/Research/Phase-III-results-of-adalimumab-biosimilar-demonstrate-equivalence
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
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