Infliximab is a monoclonal antibody, which works by binding to tumour necrosis factor-alpha (TNF-α). TNF-α is a chemical messenger (cytokine) and a key part of the autoimmune reaction. Infliximab therefore acts as an anti-inflammatory drug and is used to treat ankylosing spondylitis, Crohn’s disease, psoriatic arthritis and psoriasis, rheumatoid arthritis, ulcerative colitis.

The drug is a biosimilar of Johnson & Johnson’s blockbuster Remicade, which had sales of US$8 billion in 2010.

Although EMA has not identified the company behind the application, a likely candidate is South Korean biotechnology company Celltrion, which announced in February 2012 the successful completion of its clinical programme for its infliximab biosimilar [1].

Celltrion has a partnership with US-based generics major Hospira to develop and market eight biosimilars, including infliximab and cancer drug trastuzumab [1, 2].

Biosimilars for epoetins, filgrastim and somatropin have already been approved by EMA [3]; however, this is the first application for a biosimilar of a monoclonal antibody to be submitted to EMA.

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References

1.  GaBI Online - Generics and Biosimilars Initiative. Successful completion of biosimilar infliximab programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 27]. Available from: www.gabionline.net/Biosimilars/News/Successful-completion-of-biosimilar-infliximab-programme

2.  GaBI Online - Generics and Biosimilars Initiative. Hospira looks to biosimilars and increased use of generics for growth [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 27]. Available from: www.gabionline.net/Biosimilars/News/Hospira-looks-to-biosimilars-and-increased-use-of-generics-for-growth

3.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe