Pfizer gains Japanese approval for infliximab biosimilar

Biosimilares/Novedades | 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.

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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:

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Source: Pfizer Japan

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