EC approval for adalimumab biosimilar Imraldi

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EC approval for adalimumab biosimilar Imraldi

Biosimilars/News | Posted 01/09/2017 0 Post your comment

Samsung Bioepis announced on 25 August 2017 that it had received European Commission (EC) approval for its biosimilar adalimumab product Imraldi.

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 23 June 2017 [1].

This approval is the third anti-TNF-α biosimilar approval for Samsung Bioepis in the European Union. The company, 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].

Samsung Bioepis has also received approval for an infliximab biosimilar, Renflexis (infliximab-abda), in the US. The US Food and Drug Administration (FDA) approved Renflexis on 30 August 2016 [3].

Related article
Biosimilars approved in Europe

References
1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilar Imraldi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 1]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilar-Imraldi
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar infliximab Renflexis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 1]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-infliximab-Renflexis

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Source: Samsung Bioepis