Biosimilar etanercept submitted for approval in EU

Biosimilars/News | Posted 23/01/2015 post-comment0 Post your comment

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 21 January 2015 that its etanercept biosimilar candidate, SB4, had been accepted for review by the European Medicines Agency (EMA).

Application V15a16

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor, a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid arthritis, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

The originator product, Amgen’s Enbrel (etanercept) had 2013 sales of US$8.8 billion making it one of the top selling biologicals and a lucrative target for biosimilars developers. The patents on Enbrel are set to expire in Europe in August 2015, but will only expire in the US in November 2028 after Amgen was granted a new patent [1].

The application, which covers the same indications as Enbrel, is based on results from a phase III clinical trial in patients with moderate-to-severe rheumatoid arthritis, which compared SB4 to Enbrel [2]. This is the first application for an etanercept biosimilar to be accepted for review by EMA.

In addition to the European filings, Samsung Bioepis has stated that it intends to move forward with additional applications for regulatory approvals in other territories worldwide.

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

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1.   GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. Available from: 
2.   GaBI Online - Generics and Biosimilars Initiative. Trials to start for biosimilar infliximab and etanercept []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. Available from: 

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Source: Samsung Bioepis

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