Samsung Bioepis adalimumab biosimilar submitted to EMA

Biosimilars/News | Posted 12/08/2016 post-comment0 Post your comment

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 18 July 2016 that its adalimumab biosimilar candidate, SB5, had been accepted for review by the European Medicines Agency (EMA).

Adalimumab V13F21

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF). Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

The originator product, AbbVie’s Humira (adalimumab) had 2015 sales of US$14 billion making it one of the top-selling biologicals and a lucrative target for biosimilars developers. The patents on Humira are set to expire in Europe in April 2018 and in the US in December 2016 [1].

The application is based on results from a 52-week phase III study which, according to Samsung Bioepis, showed comparable efficacy and safety between SB5 and Humira among different treatment groups, including those who switched from Humira to SB5 [2]. This is the first application for an adalimumab biosimilar to be accepted for review by EMA.

SB5 is the third anti-TNF-α biosimilar candidate submitted for review to EMA by Samsung Bioepis. The company already gained approval for Benepali (etanercept) and Flixabi (infliximab) in January 2016 and May 2016, respectively [3].

If approved, the marketing and distribution of SB5 in Europe will be handled by Biogen Idec.

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1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 12]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Phase III results of adalimumab biosimilar demonstrate equivalence []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 12]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 12]. Available from:

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Source: Samsung Bioepis

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