Adalimumab biosimilars Amgevita and Imraldi launched in Europe

Biosimilars/News | Posted 02/11/2018 post-comment0 Post your comment

In October 2018, two adalimumab biosimilars have been launched in the European Union (EU). Amgen announced the European launch of its adalimumab biosimilar, Amgevita and Biogen announced the launch of its adalimumab biosimilar Imraldi.

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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.

Biotech giant Amgen announced on 15 October 2018 that it would launch its adalimumab biosimilar Amgevita on 16 October 2018 in the 28 EU Member States as well as in Norway, Iceland and Liechtenstein, which are members of the European Economic Area. Amgevita was the first adalimumab biosimilar to receive European Commission (EC) approval in Europe back in March 2017 [1].

Amgen has a total of 10 biosimilars in its portfolio, three of which have been approved by the EC. As well as Amgevita, the company gained EC approval for trastuzumab biosimilar Kanjinti in May 2018 and for bevacizumab biosimilar Mvasi in January 2018 [1].

On 17 October 2018, Biogen and Samsung Bioepis [a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen Idec (Biogen)] announced the European launch of their adalimumab biosimilar Imraldi. The originator infliximab, marketed across Europe by AbbVie as Humira (adalimumab), is used to treat autoimmune diseases, such as the bowel disorders Crohn’s disease and ulcerative colitis, as well as several types of arthritis. Imraldi gained EU approval on 25 August 2017 for the same 14 complex autoimmune conditions as its Humira [2].

Imraldi is the third antitumour necrosis factor (anti-TNF) biosimilar developed by Samsung Bioepis to be commercialized by Biogen across Europe. The etanercept biosimilar Benepali was approved in the EU in January 2016 and the infliximab biosimilar Flixabi was approved in May 2016 [1].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for adalimumab biosimilar Imraldi []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from:

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Source: Amgen, Biogen, Samsung Bioepis

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