This marks the first 351(k) biosimilar monoclonal antibody application to be filed in the US and the second application for a biosimilar to be filed through the US Biologics Price Competition and Innovation Act of 2009.

Sandoz, the generic drug division of Swiss drug giant Novartis, was the first company to submit an application under the biosimilars pathway, when it submitted its application for approval of the company’s biosimilar filgrastim product on 24 July 2014 [1].

Celltrion is seeking approval for Remsima (infliximab), a biosimilar of Johnson & Johnson’s (J&J) blockbuster anti-inflammatory treatment Remicade (infliximab). Remicade had worldwide sales of US$6.7 billion during 2013, according to a J&J financial statement.

Barring any setbacks, Celltrion anticipates obtaining FDA approval within one year. Once approved, Celltrion would still only be able to launch its biosimilar once the patent on Remicade expires in the US, which is currently set to be in September 2018 [2]. However, in order to pave the way for the introduction of its biosimilar, Celltrion has filed a lawsuit claiming that patents on the originator drug Remicade (infliximab) are invalid and unenforceable [3].

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

Related articles
Biosimilar infliximab receives approval in Japan and Turkey

Subsequent entry biologics approved in Canada

Remsima approved in Colombia

EC approves first monoclonal antibody biosimilar

References
1.   GaBI Online - Generics and Biosimilars Initiative. FDA accepts biosimilar filgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 29]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-biosimilar-filgrastim-application 
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 2014 Aug 29]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020 
3.   GaBI Online - Generics and Biosimilars Initiative. Celltrion files infliximab patent lawsuit in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 29]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-files-infliximab-patent-lawsuit-in-US 

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