Nichi-Iko gains Japanese approval for infliximab biosimilar

Biosimilars/News | Posted 13/10/2017 post-comment0 Post your comment

Japan-based generics maker Nichi-Iko Pharmaceutical (Nichi-Iko) announced on 27 September 2017 that it had gained Japanese approval for its infliximab biosimilar.


Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

Nichi-Iko’s product NI-071 is a biosimilar of Johnson & Johnson and Merck’s Remicade (infliximab), which had worldwide sales of US$9.3 billion in 2014, before the advent of biosimilars.

The news marks Nichi-Iko’s first biosimilar approval and is the second infliximab biosimilar to be approved in Japan. Celltrion/Nippon Kayaku’s infliximab biosimilar (infliximab biosimilar 1) was approved by Japan’s Ministry for Health Labour and Welfare (MHLW) back in July 2014 [1].

The company also announced that it has started phase III trials (RADIANCE) for its infliximab biosimilar in the US. Interestingly the company also stated that the phase III clinical trials in the US are being ‘conducted in accordance with protocols that can substantiate interchangeability (able to substitute with a brand name drug based on the judgment of the pharmacist)’. These trials, according to Nichi-Iko ‘represent the first clinical trials that will demonstrate interchangeability’.

To date in the US all biosimilars have been approved as ‘biosimilar’ but not as ‘interchangeable’ with their reference biologicals. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product [2].

Following approval in the US, marketing will be carried out by Nichi-Iko’s US subsidiary Sagent Pharmaceuticals (Sagent). Nichi-Iko acquired US generics firm Sagent Pharmaceuticals in July 2016 in order to increase its ‘growth through marketing biosimilars in the United States’.

Related article
Biosimilars of infliximab

1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 13]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 13]. 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 © 2017 Pro Pharma Communications International. All Rights Reserved.


comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010