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Biosimilar infliximab launched in Japan Posted 05/12/2014

Japanese pharma firm Nippon Kayaku announced on 28 November 2014 the launch of its infliximab biosimilar, Infliximab BS, in Japan.

The drug is a biosimilar of Johnson & Johnson’s blockbuster drug Remicade. The originator drug is indicated for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis. However, it appears that the Japanese approval only covers Crohn’s disease, rheumatoid arthritis and ulcerative colitis indications.

Infliximab BS is the first monoclonal antibody biosimilar to be approved in Japan. Nippon Kayaku began development of Infliximab BS in November 2010 as part of an agreement with Celltrion for joint development and marketing in Japan. The drug received approval in July 2014 [1].

Japan is the second largest pharmaceutical market after the US. During 2013, sales of the originator drug (Remicade) in Japan totalled approximately KRW 1 trillion. The infliximab biosimilar is already marketed in 29 countries including South Korea and parts of Europe (as Remsima).

Infliximab BS is Nippon Kayaku’s second biosimilar. The company also started marketing Filgrastim BS during 2013. The filgrastim biosimilar was produced in collaboration with development partner Teva Pharmaceutical Industries [2].

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First infliximab ‘similar biologic’ launched in India

Biosimilars approved in Japan

References
1.   GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab receives approval in Japan and Turkey [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Dec 5]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-infliximab-receives-approval-in-Japan-and-Turkey  
2.   GaBI Online - Generics and Biosimilars Initiative. Japan approves second biosimilar G-CSF [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Dec 5]. Available from: www.gabionline.net/Biosimilars/News/Japan-approves-second-biosimilar-G-CSF 

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Source: Nippon Kayaku

Comments (2)

infliximab biosimilar launched in Japan posted 05/12/2014 - by Gabriele

I would like to know it also. We start to marketing it next year

Countries in which infliximab biosimilar posted 05/12/2014 - by Andrew

I've seen in multiple places on GaBi a reference to the number of countries in which a biosimilar infliximab is currently marketed, but no list of the actual countries themselves. Would anyone happen to know exactly which countries it is currently marketed in?