Biosimilar infliximab launched in Japan

Biosimilares/Novedades | Posted 05/12/2014 post-comment2 Post your comment

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

Biosimilars V13E10

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].

Related articles
First infliximab ‘similar biologic’ launched in India

Biosimilars approved in Japan

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2014 Pro PharmaCommunications International. All Rights Reserved.

Source: Nippon Kayaku

comment icon Comments (2)
Post your comment
Posted 05/12/2014 by Gabriele
infliximab biosimilar launched in Japan

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

Posted 05/12/2014 by Andrew
Countries in which infliximab biosimilar

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?

Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010