FDA delays meeting to evaluate infliximab biosimilar

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FDA delays meeting to evaluate infliximab biosimilar

Biosimilares/Novedades | Posted 27/02/2015 0 Post your comment

The US Food and Drug Administration (FDA) has postponed a meeting of its Arthritis Advisory Committee, which was to discuss an infliximab biosimilar.

The meeting was planned on 17 March 2015 to evaluate Celltrion’s infliximab biosimilar candidate, CT-P13. The drug is a biosimilar of Johnson & Johnson’s blockbuster anti-inflammatory treatment Remicade (infliximab) and was to be considered for approval in the same indications as Remicade, i.e. Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

Celltrion filed its biosimilar application for CT-P13 back in August 2014, claiming it to be the first monoclonal antibody application to be filed in the US [1]. The South Korean biotechnology company obtained European Union approval of biosimilar infliximab in September 2013 [2].

The meeting has been postponed due to ‘information requests pending with the sponsor of the application’.

In September 2014, Celltrion and Hospira amended their 2009 partnership, giving Hospira exclusive rights to market biosimilar infliximab in the US, Canada and other undisclosed territories.

In Europe, the companies have a co-exclusive agreement which allows Hospira and Celltrion each to market biosimilar infliximab under their own brand names, a factor leading to fierce competition and price reduction.

No new date has been set for the meeting. FDA states on its website that ‘a future meeting date will be announced in the Federal Register’.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA receives application for monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/News/FDA-receives-application-for-monoclonal-antibody-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: FDA