Samsung Bioepis submits second biosimilar to EMA

Biosimilares/Novedades | Posted 03/04/2015 post-comment0 Post your comment

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 13 March 2015 that its infliximab biosimilar candidate, SB2, had been accepted for review by the European Medicines Agency (EMA).

Application V15a16

This is the second application for a biosimilar that Samsung Bioepis has submitted to EMA. The company also submitted an application for its etanercept biosimilar candidate, SB4, in January 2015 [1].

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.

The originator product, Johnson & Johnson’s Remicade (infliximab), was approved by the US Food and Drug Administration in August 1998 and by EMA in August 1999 [2]. Remicade had worldwide sales of US$6.9 billion in 2014, making it one of the world’s best selling medicines and a lucrative target for biosimilars developers.

The Samsung Bioepis biosimilar application is based on results from an extensive head-to-head preclinical data package comparing SB2 to the originator, a head-to-head phase I study in healthy volunteers and a head-to-head phase III equivalence trial in patients with moderate-to-severe rheumatoid arthritis. The biosimilar is seeking approval in the same indications as Remicade.

If authorized by EMA, SB2 will be commercialized in Europe by Biogen Idec.

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Biosimilars of infliximab

1.   GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept submitted for approval in EU []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 3]. Available from: 
2.   GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 3]. Available from: 

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Source: Samsung Bioepis

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