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FDA advisers to consider infliximab biosimilar

Biosimilars/News | Posted 13/02/2015 0 Post your comment

The US Food and Drug Administration (FDA) revealed in a Federal Register publication on 10 February 2015 that it has asked advisers to review a second biosimilar application.

The biosimilar to be considered by FDA’s Arthritis Advisory Committee on 17 March 2015 will be Celltrion’s infliximab biosimilar candidate, CT-P13. The drug is a biosimilar of Johnson & Johnson’s blockbuster anti-inflammatory treatment Remicade (infliximab). The South Korean biotechnology company filed its biosimilar application for CT-P13 back in August 2014, as the first monoclonal antibody to be filed in the US [1].

The biosimilar will be considered for approval in the same indications as Remicade, i.e. Crohn's disease, paediatric Crohn’s disease, ulcerative colitis, paediatric ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

The meeting is expected to focus on data issues since Celltrion’s product, being a monoclonal antibody, is more complex than the Sandoz filgrastim biosimilar for which advisers gave a positive recommendation in January 2015 [2].

Celltrion has already obtained approval for Remsima from over 50 countries worldwide, including most advanced regulatory agencies including Europe, Canada and Japan.

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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 13]. Available from: www.gabionline.net/Biosimilars/News/FDA-receives-application-for-monoclonal-antibody-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA advisers recommend approval of filgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 13]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisers-recommend-approval-of-filgrastim-biosimilar

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Source: FDA, US Federal Register