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.

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

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