EMA approval for adalimumab biosimilar Imraldi

Biosimilars/News | Posted 30/06/2017 post-comment0 Post your comment

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.

Approved-V13G05

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).

Related articles
Samsung Bioepis adalimumab biosimilar submitted to EMA

Biosimilars of adalimumab

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.

Source: Biogen, EMA

comment icon Comments (0)
Post your comment
Related content
EC approval of first ustekinumab biosimilar Uzpruvo
IBD 1
Biosimilars/News Posted 16/01/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010