Adalimumab biosimilar Imraldi makes waves in Europe Posted 01/02/2019

Korean biosimilars maker Samsung Bioepis has gained more than 60% of the adalimumab market in Germany for its adalimumab biosimilar, Imraldi. But it’s not just Imraldi and not just in Germany, the company’s accumulated sales for three of its biosimilars in Europe reached US$545.2 million in 2018.

In Europe, sales of three biosimilars – Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab) – increased by 44% in 2018 compared to 2017, according to data provided by Biogen, which is in charge of sales of the Samsung Bioepis biosimilars in Europe.

In Germany, Imraldi, a biosimilar of AbbVie’s Humira (adalimumab), gained a whopping 62% of the market as of 13 November 2018, according to a tally released by medical market researcher IQVIA on 10 December 2018. Imraldi was approved by the European Commission (EC) on 24 August 2018 [1] and was launched in Europe in 17 October 2018 [2]. The biosimilar managed to reach the 62% market share mark in less than a month after the South Korean drug company launched Imraldi.

The originator product, AbbVie’s Humira (adalimumab) had worldwide sales of US$18.4 billion in 2017, before the advent of biosimilars. Humira is an autoimmune drug used to treat rheumatoid arthritis, ulcerative colitis, Crohn’s disease, spondylitis ankylopoietica and psoriasis. 

The patents on Humira expired in Europe in June 2017 [3]. However, Imraldi was not the only adalimumab biosimilar to be released in Europe following the loss of patent protection. Amgen’s Amjevita (ABP 501), Fujifilm Kyowa Kirin Biologics/Mylan’s Hulio (FKB327) and Hyrimoz (GP2017) made by Sandoz were all also launched in Europe in October 2018 [2, 4].

Germany has the biggest market in Europe for Humira, representing about 28% of the European market, which was worth US$1.15 billion in 2017.

Samsung Bioepis is currently participating in a product supply tender in major European markets, including the UK, France and Italy, as well as in Germany.

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Adalimumab biosimilars Amgevita and Imraldi launched in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from:
3. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
4. GaBI Online - Generics and Biosimilars Initiative. Mylan gains nod for Ogivri and launches Hulio in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from:

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Source: Business Korea, Korea Biomedical Review, The Korea Herald, Yon Hap News

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