EMA receives second application for biosimilar infliximab

Biosimilars/News | Posted 05/10/2012 post-comment0 Post your comment

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in September 2012, the agency will be reviewing a second application for a biosimilar version of infliximab.


Infliximab is a monoclonal antibody that 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 companies behind the applications, the first infliximab biosimilar application was thought to come from South Korean biotechnology company Celltrion, which has already received approval for its product from the regulatory authorities in Korea [1].

The current list of applications received by EMA shows seven biosimilars to be under review, including one for filgrastim, one for folliptropin alpha, two for infliximab and three for human insulin.

Biosimilars for epoetins, filgrastim and somatropin have already been approved by EMA [2], and the last biosimilar approved by EMA was Hospira’s Nivestim (filgrastim) back in June 2010 [3].

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Biosimilar applications under review by EMA


1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 5]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea

2.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

3.  GaBI Online - Generics and Biosimilars Initiative. Hospira’s biosimilar filgrastim product Nivestim approved [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 5]. Available from: www.gabionline.net/Biosimilars/News/Hospira-s-biosimilar-filgrastim-product-Nivestim-approved

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Source: EMA

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