Pfizer gains Japanese approval for infliximab biosimilar

Biosimilars/News | Posted 13/07/2018 post-comment0 Post your comment

Pfizer Japan announced on 2 July 2018 that it had gained Japanese approval for its infliximab biosimilar.

IBD 2 V13J25

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.

Pfizer’s product (infliximab biosimilar 3) 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 Pfizer Japan’s first biosimilar approval in the country and is the third 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]. Then Nichi-Iko’s infliximab biosimilar (infliximab biosimilar 2) was approved in September 2017 [2].

Pfizer’s biosimilar has been approved for the same indications as other approved biosimilars, i.e. rheumatoid arthritis, ulcerative colitis, Crohn’s disease, psoriasis vulgaris and arthropathic psoriasis. In addition, it has also been approved for the new indications of psychotic psoriasis and psoriatic erythroderma.

Related article
Etanercept biosimilars submitted to EMA and launched in Japan

1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Nichi-Iko gains Japanese approval for infliximab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 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 © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: Pfizer Japan

comment icon Comments (0)
Post your comment
Related content
EMA recommends approval of eculizumab biosimilar Bekemv
Eculizumab Blood Brodsky V23C23
Biosimilars/News Posted 23/03/2023
China approves tocilizumab copy biological BAT1806
Toclizumab Roche V16G29
Biosimilars/News Posted 16/03/2023
FDA accepts application for denosumab biosimilar GP2411
Bone cells V17C04
Biosimilars/News Posted 09/03/2023
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